Connection and alignment systems and methods

ABSTRACT

A delivery system for delivering fluidic media to a user having a second housing portion configured to be selectively operatively engaged with and disengaged from a first housing portion, the first housing portion and the second housing portion configured to be slidable relative to each other to operatively engage each other; and a fluid connector supported by one the housing portions in a position to engage a reservoir supported by an other of the housing portions in a case where the first housing portion and the second housing portion are slid relative to each other to operatively engage each other.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority from U.S. Provisional Application No. 61/332,318, filed May 7, 2010, which is incorporated herein by reference in its entirety. This application is a Continuation-In-Part of U.S. patent application Ser. No. 12/650,378, filed Dec. 30, 2009, which is incorporated herein by reference in its entirety.

BACKGROUND

1. Field of the Invention

Embodiments of the present invention generally relate to medical device systems and methods, and, in specific embodiments, such systems and methods that include connection and/or alignment features for connecting and/or aligning components of medical device systems.

2. Related Art

According to modern medical techniques, certain chronic diseases may be treated by delivering a medication or other substance to the body of a patient. For example, diabetes is a chronic disease that is commonly treated by delivering defined amounts of insulin to a patient at appropriate times. Traditionally, manually operated syringes and insulin pens have been employed for delivering insulin to a patient. More recently, modern systems have been designed to include programmable pumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices, which connect to a patient, and have been configured in implantable devices, which are implanted inside of the body of a patient. External pump type delivery devices include devices designed for use in a stationary location, such as a hospital, a clinic, or the like, and further include devices configured for ambulatory or portable use, such as devices designed to be carried by a patient, or the like. External pump-type delivery devices may contain reservoirs of fluidic media, such as, but is not limited to, insulin.

External pump-type delivery devices may be connected in fluid flow communication to a patient or user-patient, for example, through suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the skin of the patient and to deliver fluidic media there through. Alternatively, the hollow tubing may be connected directly to the patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion” and Published PCT Application WO 01/70307 (PCT/US01/09139) titled “Exchangeable Electronic Cards For Infusion Devices” (each of which is owned by the assignee of the present invention), Published PCT Application WO 04/030716 (PCT/US2003/028769) titled “Components And Methods For Patient Infusion Device,” Published PCT Application WO 04/030717 (PCT/US2003/029019) titled “Dispenser Components And Methods For Infusion Device,” U.S. Patent Application Publication No. 2005/0065760 titled “Method For Advising Patients Concerning Doses Of Insulin,” and U.S. Pat. No. 6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each of which is incorporated herein by reference in its entirety.

External pump-type delivery devices may be connected in fluid-flow communication to a patient-user, for example, through suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the patient-user's skin and deliver an infusion medium to the patient-user. Alternatively, the hollow tubing may be connected directly to the patient-user as or through a cannula or set of micro-needles.

In contexts in which the hollow tubing is connected to the patient-user through a hollow needle that pierces skin of the user-patient, a manual insertion of the needle into the patient-user can be somewhat traumatic to the user-patient. Accordingly, insertion mechanisms have been made to assist the insertion of a needle into the user-patient, whereby a needle is forced by a spring to move quickly from a retracted position into an extended position. As the needle is moved into the extended position, the needle is quickly forced through the skin of the user-patient in a single, relatively abrupt motion that can be less traumatic to certain user-patients as compared to a slower, manual insertion of a needle. While a quick thrust of the needle into the skin of the user-patient may be less traumatic to some user-patients than a manual insertion, it is believed that, in some contexts, some user-patients may feel less trauma if the needle is moved a very slow, steady pace.

Examples of insertion mechanisms that may be used with and may be built into a delivery device are described in: U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006, titled “Infusion Medium Delivery system, Device And Method With Needle Inserter And Needle Inserter Device And Method,”; and U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion” (each of which is assigned to the assignee of the present invention), each of which is incorporated herein by reference in its entirety. Other examples of insertion tools are described in U.S. Patent Application Publication No. 2002/0022855, titled “Insertion Device For An Insertion Set And Method Of Using The Same” (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. Other examples of needle/cannula insertion tools that may be used (or modified for use) to insert a needle and/or cannula, are described in, for example U.S. patent application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled “Auto Insertion Device For Silhouette Or Similar Products,” and/or U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set and Method of Using the Same,” both of which are incorporated herein by reference in their entirety.

Pump-type delivery devices can allow accurate doses of insulin to be calculated and delivered automatically to a patient-user at any time during the day or night. Furthermore, when used in conjunction with glucose sensors or monitors, insulin pumps may be automatically controlled to provide appropriate doses of infusion medium at appropriate times of need, based on sensed or monitored levels of blood glucose.

Pump-type delivery devices have become an important aspect of modern medical treatments of various types of medical conditions, such as diabetes. As pump technologies improve and as doctors and patient-users become more familiar with such devices, the popularity of external medical infusion pump treatment increases and is expected to increase substantially over the next decade.

SUMMARY OF THE DISCLOSURE

A method of making a medical device may include, but is not limited to, any one of or combination of: (i) adapting a first housing portion to be carried by a user; (ii) configuring a second housing portion to be selectively operatively engaged with and disengaged from the first housing portion; (iii) providing a magnetic source having at least one of a certain magnetic field and a certain magnetic strength on at least one of the first housing portion and the second housing portion; (iv) providing a sensor for detecting at least one of the certain magnetic field and the certain magnetic strength on the other of the first housing portion and the second housing portion; (v) configuring circuitry to provide a first signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; and (vi) configuring the circuitry to provide a second signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.

In various embodiments, the first signal indicates that the first housing portion and the second housing portion have been connected. In some embodiments, the second signal indicates that the first housing portion and the second housing portion have not been connected.

In various embodiments, the first signal is a different signal from the second signal.

In various embodiments, the electronic circuitry is further configured to provide the second signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.

In some embodiments, the electronic circuitry is further configured to provide a third signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. In further embodiments, the third signal indicates that the first housing portion and the second housing portion have not been connected. In further embodiments, the second signal is different from the third signal. In further embodiments, the electronic circuitry is further configured to provide a fourth signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.

In some embodiments, the electronic circuitry comprises first electronic circuitry configured to provide a first signal in a case where the first housing portion and the second housing portion are brought together and the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts. The first electronic circuitry is further configured to provide a second signal in a case where the first housing portion and the second housing portion are brought together and the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts.

In some embodiments, the electronic circuitry further comprises second electronic circuitry configured to provide a first signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. The second electronic circuitry is further configured to provide a second signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.

In various embodiments, the set of main electrical contacts interacts with the shorting mechanism when the shorting mechanism contacts the set of main electrical contacts. The electronic circuitry is configured to provide the first signal when the first housing portion and the second housing portion are brought together. The shorting mechanism contacts the set of main electrical contacts of the plurality of electrical contacts. The sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. The electronic circuitry is further configured to provide the second signal when the first housing portion and the second housing portion are brought together, the shorting mechanism contacts the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.

In various embodiments, the shorting mechanism has a plurality of ends. Each of the ends for interacting with a respective main electrical contact of the set of main electrical contacts. The circuitry is configured to provide the first signal when the first housing portion and the second housing portion are brought together, each of the ends of the shorting mechanism interacts with the respective main electrical contact of the set of main electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. The circuitry is further configured to provide the second signal when the first housing portion and the second housing portion are brought together, at least one of the ends of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.

In some embodiments, the set of main electrical contacts comprise a first main electrical contact and a second main electrical contact. The plurality of ends of the shorting mechanism includes a first end and a second end for interacting with the first main electrical contact and the second main electrical contact. The circuitry is configured to provide the first signal when the first housing portion and the second housing portion are brought together, the first end and the second end of the shorting mechanism interacts with the first main electrical contact and the second main electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. The circuitry is further configured to provide the second signal when the first housing portion and the second housing portion are brought together, at least one of the first end and the second end of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source. In further embodiments, the shorting mechanism has a first end and a second end for interacting only with the first main electrical contact and the second main electrical contact respectively.

In various embodiments, at least one of the at least one other electrical contact is arranged between the set of main electrical contacts. In various embodiments, at least some of the set of main electrical contacts are arranged to be outermost electrical contacts of the plurality of electrical contacts.

In various embodiments, all of the at least one other electrical contact is arranged in between the set of main electrical contacts.

In various embodiments, the shorting mechanism is configured to establish an electrical connection between the set of main electrical contacts when the shorting mechanism interacts with the set of main electrical contacts. In some embodiments, the shorting mechanism comprises an electrical conductor.

In various embodiments, the set of main electrical contacts is configured to be biased toward a first position and urgeable to a second position from the first position. The set of main electrical contacts is configured to be moved to the second position when the first housing portion is engaged with the second housing portion. In some embodiments, the device further includes a bias member for biasing the set of main electrical contacts toward the first position. In further embodiments, the bias member comprises a spring. In further embodiments, the bias member comprises individual bias members, each of the individual bias members for biasing one of the set of main electrical contacts toward the first position.

In various embodiments, the plurality of the electrical contacts is configured to be biased toward a first position and urgeable to a second position from the first position. The plurality of electrical contacts is moved to the second position when the first housing portion is engaged with the second housing portion.

In various embodiments, the shorting mechanism is configured to be biased toward a first position and urgeable to a second position from the first position. The shorting mechanism is configured to be moved to the second position when the first housing portion is engaged with the second housing portion.

In various embodiments, one of the first housing portion and the second housing portion for supporting a reservoir having an interior volume for containing fluidic media.

In various embodiments, each of the main electrical contacts of the set of main electrical contacts comprises a conductive pad.

In various embodiments, the plurality of electrical contacts is provided in the second housing portion. The second housing portion has a power source for providing power to electronics in the second housing portion. At least some of the plurality of electrical contacts is configured to be engageable with an electrical source for charging the power source in the second housing portion.

In various embodiments, the plurality of electrical contacts is provided in the second housing portion, the second housing portion having programmable circuitry. At least some of the plurality of electrical contacts is configured to be engageable with an input device for programming the programmable circuitry in the second housing portion.

In various embodiments, the plurality of electrical contacts is provided in the second housing portion. The electronic circuitry is configured to determine a type of the second housing portion based on one of the plurality of electrical contacts and the shorting mechanism of the first housing portion.

In various embodiments, the shorting mechanism comprises a known resistance.

In various embodiments, the sensor is configured to provide a signal for activating control circuitry in a case where the sensor detects a gauss level exceeding a first pre-defined threshold value. In some embodiments, the sensor comprises a magnetic threshold switch. In some embodiments, the sensor is configured to provide a signal for deactivating at least one of the control circuitry and the sensor in a case where the sensor detects a gauss level exceeding a second pre-defined threshold value, wherein the second pre-defined threshold value is greater than the first pre-defined threshold value.

In various embodiments, the magnetic source has a certain magnetic field direction. The sensor is for detecting the certain magnetic field direction. The electronic circuitry is configured to provide the first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects the certain magnetic field direction. In some embodiments, the electronic circuitry is further configured to provide the second signal when the first housing portion and the second housing portion are brought together and at least one of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts and the sensor detects at least one of a magnetic field different from the certain magnetic field and the sensor detects a magnetic field direction different from the certain magnetic field direction.

In various embodiments, the certain magnetic field includes a direction. The sensor is configured for detecting the direction of the certain magnetic field.

A method of manufacturing a medical device for treating a user may include (but is not limited to) any one or combination of: (i) adapting a first housing portion to be carried by a user; (ii) configuring a second housing portion to be selectively operatively engaged with and disengaged from the first housing portion; (iii) providing a plurality of electrical contacts on at least one of the first housing portion and the second housing portion, the plurality of electrical contacts including a set of main electrical contacts and at least one other electrical contact; (iv) providing a shorting mechanism on the other of the first housing portion and the second housing portion, the shorting mechanism for interacting with the set of main electrical contacts; (v) providing a magnetic source having at least one of a certain magnetic field and a certain magnetic strength on at least one of the first housing portion and the second housing portion; (vi) configuring electronic circuitry to provide a first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; and (vii) configuring the electronic circuitry to provide a second signal when the first housing portion and the second housing portion are brought together and at least one of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system in accordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with an embodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with an embodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment of the present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a delivery device in accordance with an embodiment of the present invention;

FIG. 7 shows a schematic side view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system in accordance with an embodiment of the present invention;

FIG. 8 shows a schematic side view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system in accordance with an embodiment of the present invention;

FIG. 9 shows a partially exploded view of a delivery system in accordance with an embodiment of the present invention;

FIG. 10 shows a schematic top view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system in accordance with an embodiment of the present invention;

FIG. 11 shows a schematic top view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system in accordance with an embodiment of the present invention;

FIGS. 12 and 13 each show a perspective view of a connection arrangement for a disposable housing portion and an injection site module in accordance with an embodiment of the present invention;

FIGS. 14 and 15 each show a perspective view of a connection arrangement for a disposable housing portion and an injection site module in accordance with an embodiment of the present invention;

FIGS. 16-19 each show a perspective view of a connection arrangement for a disposable housing portion and an injection site module in accordance with an embodiment of the present invention;

FIGS. 20A-20C illustrate a cutaway view of a portion of medical device system in accordance with an embodiment of the present invention;

FIGS. 21A-21C illustrate a bottom down view of a portion of a medical device system in accordance with an embodiment of the present invention;

FIGS. 22A-22C illustrate a portion of medical device system in accordance with an embodiment of the present invention;

FIG. 23 illustrates a portion of a medical device system in accordance with an embodiment of the present invention;

FIG. 24 illustrates a portion of a medical device system in accordance with an embodiment of the present invention;

FIGS. 25A-25C illustrate a general representation of a medical device system in accordance with an embodiment of the present invention;

FIG. 26 illustrates a general representation of a medical device system in accordance with an embodiment of the present invention;

FIGS. 27A and 27B illustrate a general representation of a medical device system in accordance with an embodiment of the present invention;

FIGS. 28A and 28B illustrate a general representation of a medical device system in accordance with an embodiment of the present invention;

FIGS. 29A and 29B illustrate a general representation of a medical device system in accordance with an embodiment of the present invention;

FIG. 30 illustrates a block diagram of an electrical configuration of a medical device system in accordance with an embodiment of the present invention; and

FIG. 31 illustrates an exemplary chart in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of a system 10 in accordance with an embodiment of the present invention. The system 10 may include a delivery device 12. The system 10 may further include a sensing device 14, a command control device (CCD) 16, and a computer 18. In various embodiments, the delivery device 12 and the sensing device 14 may be secured at desired locations on the body 5 of a patient or user-patient 7. The locations at which the delivery device 12 and the sensing device 14 are secured to the body 5 of the user-patient 7 in FIG. 1 are provided only as representative, non-limiting, examples. It should be noted user-patient as used throughout the disclosure may include patient-user, patient, or user (e.g., a patient, a medical professional, or other treating the patient).

The system 10, the delivery device 12, the sensing device 14, the CCD 16, and computer 18 may be similar to those described in the following U.S. patent applications that were assigned to the assignee of the present invention, where each of following patent applications is incorporated herein by reference in its entirety: (i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, “Infusion Device And Method With Disposable Portion”; (ii) U.S. patent application Ser. No. 11/515,225, filed Sep. 1, 2006, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (iii) U.S. patent application Ser. No. 11/588,875, filed Oct. 27, 2006, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; (iv) U.S. patent application Ser. No. 11/588,832, filed Oct. 27, 2006, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (v) U.S. patent application Ser. No. 11/588,847, filed Oct. 27, 2006, “Infusion Medium Delivery Device And Method With Compressible Or Curved Reservoir Or Conduit”; (vi) U.S. patent application Ser. No. 11/589,323, filed Oct. 27, 2006, “Infusion Pumps And Methods And Delivery Devices And Methods With Same”; (vii) U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; (viii) U.S. patent application Ser. No. 11/602,052, filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; (ix) U.S. patent application Ser. No. 11/602,428, filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; (x) U.S. patent application Ser. No. 11/602,113, filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; (xi) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (xii) U.S. patent application Ser. No. 11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (xiii) U.S. patent application Ser. No. 11/606,703, filed Nov. 30, 2006, “Infusion Pumps And Methods And Delivery Devices And Methods With Same”; (xiv) U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006, “Infusion Pumps And Methods And Delivery Devices And Methods With Same”; U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006, “Infusion Medium Delivery Device And Method With Compressible Or Curved Reservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993, filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method With Compressible Or Curved Reservoir Or Conduit”; U.S. patent application Ser. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; (xvi) U.S. patent application Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; (xviii) U.S. patent application Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; and (xix) U.S. patent application Ser. No. 11/759,725, filed Jun. 7, 2007, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (xx) U.S. patent application Ser. No. 11/606,837, filed Nov. 30, 2006, “Method And Apparatus For Enhancing The Integrity Of An Implantable Sensor Device”; (xxi) U.S. patent application Ser. No. 11/702,713, filed Feb. 5, 2007, “Selective Potting For Controlled Failure And Electronic Devices Employing The Same”; (xxii) U.S. patent application Ser. No. 11/843,601, filed Aug. 22, 2007, “System And Method For Sensor Recalibration”; (xxiii) U.S. patent application Ser. No. 11/868,898, filed Oct. 8, 2007, “Multilayer Substrate”; (xxiv) U.S. patent application Ser. No. 11/964,649, filed Dec. 26, 2007, “System And Methods Allowing For Reservoir Air Bubble Management”; (xxv) U.S. patent application Ser. No. 12/111,751, filed Apr. 29, 2008, “Systems And Methods For Reservoir Filling”; (xxvi) U.S. patent application Ser. No. 12/111,815, filed Apr. 29, 2008, “Systems And Methods For Reservoir Air Bubble Management”; (xxvii) U.S. patent application Ser. No. 11/924,402, filed Oct. 25, 2007, “Sensor Substrate And Method Of Fabricating Same”; (xxviii) U.S. patent application Ser. No. 11/929,428, filed Oct. 30, 2007, “Telemetry System And Method With Variable Parameters”; (xxix) U.S. patent application Ser. No. 11/965,578, filed Dec. 27, 2007, “Reservoir Pressure Equalization Systems And Methods”; (xxx) U.S. patent application Ser. No. 12/107,580, filed Apr. 22, 2008, “Automative Filling Systems And Methods”; (xxxi) U.S. patent application Ser. No. 11/964,663, filed Dec. 26, 2007, “Medical Device With Full Options And Selective Enablement/Disablement”; (xxxi) U.S. patent application Ser. No. 10/180,732, filed Jun. 26, 2002, “Communication Station And Software For Interfacing With An Infusion Pump, Analyte Monitor, Analyte Meter, And/or the like”; (xxxiii) U.S. patent application Ser. No. 12/099,738, filed Apr. 8, 2008, “Systems And Methods Allowing For Reservoir Air Bubble Management”; (xxxiv) U.S. patent application Ser. No. 12/027,963, filed Feb. 7, 2008, “Adhesive Patch Systems And Methods”; (xxxv) U.S. patent application Ser. No. 12/121,647, filed May 15, 2008, “Multi-Lumen Catheter”; (xxxvi) U.S. Patent Provisional App. Ser. No. 61/044,269, filed Apr. 11, 2008, “Reservoir Plunger Head Systems And Methods”; (xxxvii) U.S. Patent App. Ser. No. 61/044,292, filed Apr. 11, 2008, “Reservoir Barrier Layer Systems And Methods”; (xxxviii) U.S. Patent Provisional App. Ser. No. 61/044,322, filed Apr. 11, 2008, “Reservoir Seal Retainer Systems And Methods”; (xxxix) U.S. patent application Ser. No. 12/179,502, filed Jul. 24, 2008, “Method For Formulating And Immobilizing A Matrix Protein And A Matrix Protein For Use In A Sensor”; (xl) U.S. patent application Ser. No. 12/336,367, filed Dec. 16, 2008, “Needle Insertions Systems And Methods”; (xli) U.S. patent application Ser. No. 12/166,210, filed Jul. 1, 2008, “Electronic Device For Controlled Failure”; (xlii) U.S. patent application Ser. No. 12/271,134, filed Nov. 14, 2008, “Multilayer Circuit Devices And Manufacturing Methods Using Electroplated Sacrificial Structures”; (xliii) U.S. patent application Ser. No. 12/171,971, filed Jul. 11, 2008, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; (xliv) U.S. patent application Ser. No. 12/189,077, filed Aug. 8, 2008, “Packaging System”; (xlv) U.S. patent application Ser. No. 12/179,536, filed Jul. 24, 2008, “Real Time Self-Adjusting Calibration Algorithm”; (xlvii) U.S. patent application Ser. No. 12/277,186, filed Nov. 24, 2008, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; (xlviii) U.S. patent application Ser. No. 12/211,783, filed Sep. 16, 2008, “Implantable Sensor Method And System”; (xlix) U.S. patent application Ser. No. 12/247,945, filed Oct. 8, 2008, “Infusion Medium Delivery Device And Method With Drive Device For Driving Plunger In Reservoir”; (1) U.S. patent application Ser. No. 12/360,077, filed Jan. 26, 2009, “Reservoir Barrier Layer Systems And Methods”; (li) U.S. patent application Ser. No. 12/345,362, filed Dec. 29, 2008, “Reservoir Seal Retainer Systems And Methods”; (lii) U.S. patent application Ser. No. 12/353,181, filed Jan. 13, 2009, “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; and (liii) U.S. patent application Ser. No. 12/360,813, filed Jan. 27, 2009, “Multi-Position Infusion Set Device And Process.” In other embodiments, the system 10, delivery device 12, sensing device 14, CCD 16, and computer 18 may have other suitable configurations.

The delivery device 12 may be configured to deliver fluidic media to the body 5 of the user-patient 7. In various embodiments, fluidic media may include a liquid, a fluid, a gel, or the like. In some embodiments, fluidic media may include a medicine or a drug for treating a disease or a medical condition. For example, fluidic media may include insulin for treating diabetes, or may include a drug for treating pain, cancer, a pulmonary disorder, HIV, or the like. In some embodiments, fluidic media may include a nutritional supplement, a dye, a tracing medium, a saline medium, a hydration medium, or the like.

The sensing device 14 may include a sensor, a monitor, or the like, for providing sensor data or monitor data. In various embodiments, the sensing device 14 may be configured to sense a condition of the user-patient 7. For example, the sensing device 14 may include electronics and enzymes reactive to a biological condition, such as a blood glucose level, or the like, of the user-patient 7.

In various embodiments, the sensing device 14 may be secured to the body 5 of the user-patient 7 or embedded in the body 5 of the user-patient 7 at a location that is remote from the location at which the delivery device 12 is secured to the body 5 of the user-patient 7. In various other embodiments, the sensing device 14 may be incorporated within the delivery device 12. In other embodiments, the sensing device 14 may be separate and apart from the delivery device, and may be, for example, part of the CCD 16. In such embodiments, the sensing device 14 may be configured to receive a biological sample, analyte, or the like, to measure a condition of the user-patient 7.

In further embodiments, the sensing device 14 and/or the delivery device 12 may utilize a closed-loop system. Examples of sensing devices and/or delivery devices utilizing closed-loop systems may be found at, but are not limited to, the following references: (i) U.S. Pat. No. 6,088,608, entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii) U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based Monitoring Systems Having Improved Longevity Due To Improved Exterior Surfaces”; (iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-Based Monitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No. 6,740,072, entitled “System And Method For Providing Closed Loop Infusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled “Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat. No. 7,323,142, entitled “Sensor Substrate And Method Of Fabricating Same”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22, 1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional Patent App. Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “Sensing Apparatus and Process”, all of which are incorporated herein by reference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense a condition of the user-patient 7, such as, but not limited to, blood glucose level, or the like. The delivery device 12 may be configured to deliver fluidic media in response to the condition sensed by the sensing device 14. In turn, the sensing device 14 may continue to sense a new condition of the user-patient, allowing the delivery device 12 to deliver fluidic media continuously in response to the new condition sensed by the sensing device 14 indefinitely. In some embodiments, the sensing device 14 and/or the delivery device 12 may be configured to utilize the closed-loop system only for a portion of the day, for example only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, and the computer 18 may include transmitter, receiver, or transceiver electronics that allow for communication with other components of the system 10. The sensing device 14 may be configured to transmit sensor data or monitor data to the delivery device 12. The sensing device 14 may also be configured to communicate with the CCD 16. The delivery device 12 may include electronics and software that are configured to analyze sensor data and to deliver fluidic media to the body 5 of the user-patient 7 based on the sensor data and/or preprogrammed delivery routines.

The CCD 16 and the computer 18 may include electronics and other components configured to perform processing, delivery routine storage, and to control the delivery device 12. By including control functions in the CCD 16 and/or the computer 18, the delivery device 12 may be made with more simplified electronics. However, in some embodiments, the delivery device 12 may include all control functions, and may operate without the CCD 16 and the computer 18. In various embodiments, the CCD 16 may be a portable electronic device. In various embodiments, the delivery device 12 and/or the sensing device 14 may be configured to transmit data to the CCD 16 and/or the computer 18 for display or processing of the data by the CCD 16 and/or the computer 18.

In some embodiments, the sensing device 14 may be integrated into the CCD 16. Such embodiments may allow the user-patient to monitor a condition by providing, for example, a sample of his or her blood to the sensing device 14 to assess his or her condition. In some embodiments, the sensing device 14 and the CCD 16 may be for determining glucose levels in the blood and/or body fluids of the user-patient without the use of, or necessity of, a wire or cable connection between the delivery device 12 and the sensing device 14 and/or the CCD 16.

In some embodiments, the CCD 16 may be for providing information to the user-patient that facilitates the user-patient's subsequent use of a drug delivery system. For example, the CCD 16 may provide information to the user-patient to allow the user-patient to determine the rate or dose of medication to be administered into the body of the user-patient. In other embodiments, the CCD 16 may provide information to the delivery device 12 to control the rate or dose of medication administered into the body of the user-patient

Examples of the types of communications and/or control capabilities, as well as device feature sets and/or program options may be found in the following references: (i) U.S. patent application Ser. No. 10/445,477, filed May 27, 2003, entitled “External Infusion Device with Remote Programming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii) U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled “Handheld Personal Data Assistant (PDA) with a Medical Device and Method of Using the Same”; and (iii) U.S. patent application Ser. No. 09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for Infusion Devices and Methods of Using the Same,” all of which are incorporated herein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with an embodiment of the present invention. The system 10 in accordance with the embodiment illustrated in FIG. 2 includes the delivery device 12 and the sensing device 14. The delivery device 12 in accordance with an embodiment of the present invention may include a disposable housing 20, a durable housing 30, and a reservoir system 40. The delivery device 12 may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of a user-patient or that ordinarily contact fluidic media during operation of the delivery device 12 may be considered as a disposable portion of the delivery device 12. For example, a disposable portion of the delivery device 12 may include the disposable housing 20 and the reservoir system 40. The disposable portion of the delivery device 12 may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do not ordinarily contact the body of the user-patient or fluidic media during operation of the delivery device 12 may be considered as a durable portion of the delivery device 12. For example, a durable portion of the delivery device 12 may include the durable housing 30, electronics (not shown in FIG. 2), a drive device having a motor and drive linkage (not shown in FIG. 2), and the like. Elements of the durable housing portion of the delivery device 12 are typically not contaminated from contact with the user-patient or fluidic media during normal operation of the delivery device 12 and, thus, may be retained for re-use with replaced disposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 may support the reservoir system 40 and has a bottom surface (facing downward and into the page in FIG. 2) configured to secure to the body of the user-patient. An adhesive may be employed at an interface between the bottom surface of the disposable housing 20 and the skin of the user-patient to adhere the disposable housing 20 to the skin of the user-patient. In various embodiments, the adhesive may be provided on the bottom surface of the disposable housing 20, with a peelable cover layer covering the adhesive material. In this manner, the cover layer may be peeled off to expose the adhesive material, and the adhesive side of the disposable housing 20 may be placed against the user-patient, for example against the skin of the user-patient. Thus in some embodiments, the delivery device 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remaining portions of the delivery device 12 may be worn or otherwise attached on or underneath clothing of the user-patient. Similarly, the delivery device 12 may be supported by any suitable manner, such as, but not limited to, on a belt, in a pocket, and the like. Representative examples of such delivery devices 12, and delivery devices in general, may include, but is not limited to, the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 Insulin Pump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715 Insulin Pump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm 712R Insulin Pump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin Pump, and any other derivatives thereof.

The reservoir system 40 may be configured for containing or holding fluidic media, such as, but not limited to insulin. In various embodiments, the reservoir system 40 may include a hollow interior volume for receiving fluidic media, such as, but not limited to, a cylinder-shaped volume, a tubular-shaped volume, or the like. In some embodiments, the reservoir system 40 may be provided as a cartridge or canister for containing fluidic media. In various embodiments, the reservoir system 40 can be refilled with fluidic media. In further embodiments, the reservoir system 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 in any suitable manner. For example, the disposable housing 20 may be provided with projections or struts (not shown), or a trough feature (not shown), for holding the reservoir system 40. In some embodiments, the reservoir system 40 may be supported by the disposable housing 20 in a manner that allows the reservoir system 40 to be removed from the disposable housing 20 and replaced with another reservoir. Alternatively, or in addition, the reservoir system 40 may be secured to the disposable housing 20 by a suitable adhesive, a strap, or other coupling structure.

In various embodiments, the reservoir system 40 may include at least one port 41 for allowing fluidic media to flow into and/or flow out of the interior volume of the reservoir system 40. In some embodiments, the infusion path 50 may include a connector 56, a tube 54, and a needle apparatus 52. The connector 56 of the infusion path 50 may be connectable to the port 41 of the reservoir system 40. In various embodiments, the disposable housing 20 may be configured with an opening near the port 41 of the reservoir system 40 for allowing the connector 56 of the infusion path 50 to be selectively connected to and disconnected from the port 41 of the reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 may be covered with or supports a septum (not shown in FIG. 2), such as a self-sealing septum, or the like. The septum may be configured to prevent fluidic media from flowing out of the reservoir system 40 through the port 41 when the septum is not pierced. In addition, in various embodiments, the connector 56 of the infusion path 50 may include a needle for piercing the septum covering the port 41 of the reservoir system 40 to allow fluidic media to flow out of the interior volume of the reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patent application Ser. No. 10/328,393, filed Dec. 22, 2003, entitled “Reservoir Connector,” which is incorporated herein by reference in its entirety. In other alternatives, non-septum connectors such as Luer locks, or the like may be used. In various embodiments, the needle apparatus 52 of the infusion path 50 may include a needle that is able to puncture the skin of the user-patient. In addition, in various embodiments, the tube 54 connects the connector 56 with the needle apparatus 52 and may be hollow, such that the infusion path 50 is able to provide a path to allow for the delivery of fluidic media from the reservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance with various embodiments of the present invention includes a housing shell configured to mate with and secure to the disposable housing 20. The durable housing 30 and the disposable housing 20 may be provided with correspondingly shaped grooves, notches, tabs, or other suitable features that allow the two parts to connect together easily, by manually pressing the two housings together, by twist or threaded connection, in a friction fit connection, in a slidable connection, and/or other suitable manner of connecting the parts that is well known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposable housing 20 may be connected to each other using a twist action. The durable housing 30 and the disposable housing 20 may be configured to be separable from each other when a sufficient force is applied to disconnect the two housings from each other. For example, in some embodiments the disposable housing 20 and the durable housing 30 may be snapped together by friction fitting. In various embodiments, a suitable seal, such as an o-ring seal, may be placed along a peripheral edge of the durable housing 30 and/or the disposable housing 20 to provide a seal against water entering between the durable housing 30 and the disposable housing 20.

The durable housing 30 of the delivery device 12 may support a drive device (not shown in FIG. 2) that may include a motor and a drive device linkage portion. The drive device may be configured to apply a force to fluidic media within the reservoir system 40 to force fluidic media out of the reservoir system 40 and into an infusion path, such as the infusion path 50, for delivery to a user-patient. For example, in some embodiments, an electrically driven motor 84 (refer to FIGS. 5B and 5C) may be mounted within the durable housing 30 with appropriate linkage for operatively coupling the motor 84 to a plunger arm (refer to FIGS. 6A-6C) connected to a plunger head (refer to FIGS. 6A-6C) arranged within the reservoir system 40. The electrically driven motor may be configured to drive the plunger head in a direction to force fluidic media out of the port 41 of the reservoir system 40 and to the user-patient.

Also, in some embodiments, the motor 84 may be controllable to reverse direction to move the plunger arm 60 and the plunger head to cause fluid to be drawn into the reservoir system 40 from a patient. The motor 84 may be arranged within the durable housing 30 and the reservoir system 40 may be correspondingly arranged on the disposable housing 20, such that the operable engagement of the motor 84 with the plunger head, through the appropriate linkage, occurs automatically upon the user-patient connecting the durable housing 30 with the disposable housing 20 of the delivery device 12. Further examples of linkage and control structures may be found in, but are not limited to, U.S. patent application Ser. No. 09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for Infusion Devices and Methods of Using the Same”; U.S. Patent Pub. No. 2006/0264894 (Ser. No. 11/211,095), filed Aug. 23, 2005, entitled “Infusion Device and Method with Disposable Portion”; U.S. patent application Ser. No. 11/210,467, filed Aug. 23, 2005, entitled “Infusion Device and Method With Drive In Separable Durable Housing Portion”; U.S. patent application Ser. No. 11/211,150, filed Aug. 23, 2005, entitled “Pump Assembly and Method For Infusion Device”; U.S. patent application Ser. No. 11/210,455, filed Aug. 23, 2005, entitled “Reservoir Support And Method For Infusion Device”; and U.S. Pat. No. 6,485,465, filed Mar. 27, 2001, entitled “Methods, Apparatuses, and Uses for Infusion Pump Fluid Pressure and Force Detection,” all of which are incorporated herein by reference in its entirety.

In various embodiments, the durable housing 30 and the disposable housing 20 may be made of suitably rigid materials that maintain their shape, yet provide sufficient flexibility and resilience to effectively connect together and disconnect, as described above. The material of the disposable housing 20 may be selected for suitable compatibility with skin. For example, the disposable housing 20 and the durable housing 30 of the delivery device 12 may be made of any suitable plastic, metal, composite material, or the like. The disposable housing 20 may be made of the same type of material or a different material relative to the durable housing 30. In some embodiments, the disposable housing 20 and the durable housing 30 may be manufactured by injection molding or other molding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relatively flexible material, such as a flexible silicone, plastic, rubber, synthetic rubber, or the like. By forming the disposable housing 20 of a material capable of flexing with the skin of a user-patient, a greater level of user-patient comfort may be achieved when the disposable housing 20 is secured to the skin of the user-patient. In addition, a flexible disposable housing 20 may result in an increase in site options on the body of the user-patient at which the disposable housing 20 may be secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 is connected to the sensing device 14 through a connection element 17 of the sensing device 14. The sensing device 14 may include a sensor 15 that includes any suitable biological or environmental sensing device, depending upon a nature of a treatment to be administered by the delivery device 12. For example, in the context of delivering insulin to a diabetes patient, the sensor 15 may include a blood glucose sensor, or the like.

In some embodiments, the sensor 15 may include a continuous glucose sensor. The continuous glucose sensor may be implantable within the body of the user-patient. In other embodiments, the continuous glucose sensor may be located externally, for example on the skin of the user-patient, or attached to clothing of the user-patient. In such embodiments, fluid may be drawn continually from the user-patient and sensed by the continuous glucose sensor. In various embodiments, the continuous glucose sensor may be configured to sense and/or communicate with the CCD 16 continuously. In other embodiments, the continuous glucose sensor may be configured to sense and/or communicate with the CCD 16 intermittently, for example sense glucose levels and transmit information every few minutes. In various embodiments, the continuous glucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of a user-patient or, in other embodiments, may be an implantable sensor that is located in an implant site within the body of the user-patient. In further alternatives, the sensor may be included with as a part or along side the infusion cannula and/or needle, such as for example as shown in U.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005, entitled “Dual Insertion Set,” which is incorporated herein by reference in its entirety. In the illustrated example of FIG. 2, the sensor 15 is an external sensor having a disposable needle pad that includes a needle for piercing the skin of the user-patient and enzymes and/or electronics reactive to a biological condition, such as blood glucose level or the like, of the user-patient. In this manner, the delivery device 12 may be provided with sensor data from the sensor 15 secured to the user-patient at a site remote from the location at which the delivery device 12 is secured to the user-patient.

While the embodiment shown in FIG. 2 may include a sensor 15 connected by the connection element 17 for providing sensor data to sensor electronics (not shown in FIG. 2) located within the durable housing 30 of the delivery device 12, other embodiments may employ a sensor 15 located within the delivery device 12. Yet other embodiments may employ a sensor 15 having a transmitter for communicating sensor data by a wireless communication link with receiver electronics (not shown in FIG. 2) located within the durable housing 30 of the delivery device 12. In various embodiments, a wireless connection between the sensor 15 and the receiver electronics within the durable housing 30 of the delivery device 12 may include a radio frequency (RF) connection, an optical connection, or another suitable wireless communication link. Further embodiments need not employ the sensing device 14 and, instead, may provide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the delivery device 12 from durable elements, the disposable elements may be arranged on the disposable housing 20, while durable elements may be arranged within a separable durable housing 30. In this regard, after a prescribed number of uses of the delivery device 12, the disposable housing 20 may be separated from the durable housing 30, so that the disposable housing 20 may be disposed of in a proper manner. The durable housing 30 may then be mated with a new (un-used) disposable housing 20 for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordance with another embodiment of the present invention. The delivery device 12 of the embodiment of FIG. 3 is similar to the delivery device 12 of the embodiment of FIG. 2. While the delivery device 12 in the embodiment illustrated in FIG. 2 provides for the durable housing 30 to cover the reservoir system 40, the delivery device 12 in the embodiment of FIG. 3 provides for the durable housing 30 to secure to the disposable housing 20 without covering the reservoir system 40. The delivery device 12 of the embodiment illustrated in FIG. 3 includes the disposable housing 20, and the disposable housing 20 in accordance with the embodiment illustrated in FIG. 3 includes a base 21 and a reservoir retaining portion 24. In one embodiment, the base 21 and reservoir retaining portion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 may be configured to be securable to a body of a user-patient. The reservoir-retaining portion 24 of the disposable housing 20 is configured to house the reservoir system 40. The reservoir-retaining portion 24 of the disposable housing 20 may be configured to have an opening to allow for the port 41 of the reservoir system 40 to be accessed from outside of the reservoir-retaining portion 24 while the reservoir system 40 is housed in the reservoir-retaining portion 24. The durable housing 30 may be configured to be attachable to and detachable from the base 21 of the disposable housing 20. The delivery device 12 in the embodiment illustrated in FIG. 3 includes a plunger arm 60 that is connected to or that is connectable to a plunger head (not shown in FIG. 3) within the reservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of the embodiment of FIG. 3. The delivery device 12 of the embodiment illustrated in FIG. 4 includes the disposable housing 20, the durable housing 30, and the infusion path 50. The disposable housing 20 in the embodiment of FIG. 4 includes the base 21, the reservoir-retaining portion 24, and a peelable cover layer 25. The peelable cover layer 25 may cover an adhesive material on the bottom surface 22 of the base 21. The peelable cover layer 25 may be configured to be peelable by a user-patient to expose the adhesive material on the bottom surface 22 of the base 21. In some embodiments, there may be multiple adhesive layers on the bottom surface 22 of the base 21 that are separated by peelable layers.

The infusion path 50 in accordance with the embodiment of the present invention illustrated in FIG. 4 includes the needle 58 rather than the connector 56, the tube 54, and the needle apparatus 52 as shown in the embodiment of FIG. 2. The base 21 of the disposable housing 20 may be provided with an opening or pierceable wall in alignment with a tip of the needle 58, to allow the needle 58 to pass through the base 21 and into the skin of a user-patient under the base 21, when extended. In this manner, the needle 58 may be used to pierce the skin of the user-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula (not shown in FIG. 4), such that upon piercing the skin of the user-patient with the needle 58, an end of the hollow cannula is guided through the skin of the user-patient by the needle 58. Thereafter, the needle 58 may be removed, leaving the hollow cannula in place with one end of the cannula located within the body of the user-patient and the other end of the cannula in fluid flow connection with fluidic media within the reservoir system 40. Accordingly, fluidic media may be conveyed from the reservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (e.g., FIG. 3) in accordance with an embodiment of the present invention. FIG. 5B illustrates a section view of the durable portion 8 in accordance with an embodiment of the present invention. FIG. 5C illustrates another section view of the durable portion 8 in accordance with an embodiment of the present invention. With reference to FIGS. 5A, 5B, and 5C, in various embodiments, the durable portion 8 may include the durable housing 30, and a drive device 80. The drive device 80 may include a motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interior volume for housing the motor 84, the drive device linkage portion 82, other electronic circuitry, and a power source (not shown in FIGS. 5A, 5B, and 5C). In addition, in various embodiments, the durable housing 30 may be configured with an opening 32 for receiving a plunger arm 60 (refer to FIG. 3). In addition, in various embodiments, the durable housing 30 may include one or more connection members 34, such as tabs, insertion holes, or the like, for connecting with the base 21 of the disposable housing 20 (e.g., FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12 (e.g., FIG. 3) in accordance with an embodiment of the present invention. FIG. 6B illustrates a section view of the disposable portion 9 in accordance with an embodiment of the present invention. FIG. 6C illustrates another section view of the disposable portion 9 in accordance with an embodiment of the present invention. With reference to FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion 9 includes the disposable housing 20, the reservoir system 40, the plunger arm 60, and a plunger head 70. The plunger head 70 may be made of Bromobutyl rubber, silicone rubber, or any other suitable material and/or any derivative thereof. In some embodiments, the disposable housing 20 may include the base 21 and the reservoir-retaining portion 24. In various embodiments, the base 21 may include a top surface 23 having one or more connection members 26, such as tabs, grooves, or the like, for allowing connections with the one or more connection members 34 of embodiments of the durable housing 30 (e.g., FIG. 5B).

In various embodiments, the reservoir system 40 may be housed within the reservoir retaining portion 24 of the disposable housing 20, and the reservoir system 40 may be configured to hold fluidic media. In addition, in various embodiments, the plunger head 70 may be disposed at least partially within the reservoir system 40 and may be moveable within the reservoir system 40 to allow fluidic media to fill into the reservoir system 40 and to force fluidic media out of the reservoir system 40. In some embodiments, the plunger arm 60 may be connected to or is connectable to the plunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 may extend to outside of the reservoir-retaining portion 24 of the disposable housing 20. In various embodiments, the plunger arm 60 may have a mating portion for mating with the drive device linkage portion 82 of the drive device 80 (e.g., FIG. 5C). With reference to FIGS. 5C and 6C, in some embodiments, the durable housing 30 may be snap fitted onto the disposable housing 20, whereupon the drive device linkage portion 82 automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fitted together with the drive device linkage portion 82 engaging or mating with the plunger arm 60, the motor 84 may be controlled to drive the drive device linkage portion 82. Accordingly, the plunger arm 60 may be moved to cause the plunger head 70 to move within the reservoir system 40. When the interior volume of the reservoir system 40 is sufficiently filled with fluidic media and an infusion path is provided from the reservoir system 40 to the body of the user-patient, the plunger head 70 may be moved within the reservoir system 40 to force fluidic media from the reservoir system 40 to the user-patient via the infusion path.

In various embodiments, once the reservoir system 40 has been sufficiently emptied or otherwise requires replacement, the user-patient may simply remove the durable housing 30 from the disposable housing 20, and replace the disposable portion 9, including the reservoir system 40, with a new disposable portion having a new reservoir. The durable housing 30 may be connected to the new disposable housing of the new disposable portion, and the delivery device including the new disposable portion may be secured to the skin of a user-patient, or otherwise attached to the user-patient.

In various other embodiments, rather than replacing the entire disposable portion 9 every time the reservoir system 40 is emptied, the reservoir system 40 may be refilled with fluidic media. In some embodiments, the reservoir system 40 may be refilled while remaining within the reservoir retaining portion 24 (e.g., FIG. 6B) of the disposable housing 20. In addition, in various embodiments, the reservoir system 40 may be replaced with a new reservoir (not shown), while the disposable housing 20 may be re-used with the new reservoir. In such embodiments, the new reservoir may be inserted into the disposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, the delivery device 12 may include reservoir status circuitry (not shown), and the reservoir system 40 may include reservoir circuitry (not shown). In various embodiments, the reservoir circuitry stores information such as, but not limited to, at least one of (i) an identification string identifying the reservoir system 40; (ii) a manufacturer of the reservoir system 40; (iii) contents of the reservoir system 40; (iv) an amount of contents in the reservoir system 40; or the like. In some embodiments, the delivery device 12 may include the reservoir status circuitry, and the reservoir status circuitry may be configured to read data from the reservoir circuitry when the reservoir system 40 is inserted into the disposable portion 9.

In various embodiments, the reservoir status circuitry may be further configured to store data to the reservoir circuitry after at least some of the contents of the reservoir system 40 have been transferred out of the reservoir system 40 to update information in the reservoir circuitry. Such information may be related to, but is not limited to, an amount of fluidic media remaining in the reservoir system 40, an amount of fluidic media already delivered, plunger head 60 location, pressure within the reservoir system, or the like.

In some embodiments, the reservoir status circuitry may be configured to store data to the reservoir circuitry to update information in the reservoir circuitry related to an amount of contents remaining in the reservoir system 40 when the reservoir system 40 is inserted into the disposable portion 9. In some embodiments, the delivery device 12 may include the reservoir status circuitry and the reservoir system 40 may include the reservoir circuitry, and the reservoir status circuitry may selectively inhibit use of the delivery device 12 or may selectively provide a warning signal based on information read by the reservoir status circuitry from the reservoir circuitry.

FIGS. 7-19 illustrate various examples of connection structures for connecting a first housing portion and a second housing portion of a medical device system according to various embodiments of the present invention. The medical device systems of FIGS. 7-19 may include features similar to the medical device systems discussed throughout the disclosure or employed as an embodiment of the medical devices (e.g., delivery device 12 in FIGS. 1-6C) discussed throughout the disclosure. Although the medical device systems may include features similar or used with the embodiments of FIGS. 1-6C, it should be understood that the medical device systems may also include some or all of the same features and operate in a manner similar to that shown and described in the embodiments of FIGS. 20-31. In addition, some or all of the features shown in FIGS. 1-6C and 20-31 may be combined in various ways and included in the embodiments shown in FIGS. 7-19. Likewise, it should be understood that any of the features of the embodiments of FIGS. 7-19 may be combined or otherwise incorporated into any of the other embodiments of FIGS. 7-19 as well as any other embodiment herein discussed.

In various embodiments, a medical device system 100 having a disposable housing portion (e.g., 20 in FIG. 3) may be provided with a base portion 21 that may be secured to skin of a patient-user by, for example, but not limited to, an adhesive material, such as that described herein, provided on a bottom surface of the base portion 21. That arrangement is generally represented in side view in FIG. 7. In such an arrangement, an adhesive material 101 may be provided on a bottom surface (i.e., skin-facing surface) of the base 21 of the disposable housing portion 20. With reference to FIGS. 2, 3, and 7, a durable housing portion 30 may be configured to be arranged on the base 21 of the disposable housing portion 20 to engage and connect to the base 21 and the disposable housing portion 20. In such an arrangement, the base 21 may be disposed between the durable housing portion 30 and the skin of the patient-user such that only the base 21 of the disposable housing portion 20 remains in contact with the skin of the patient-user.

However, in other embodiments, a durable housing portion 30 and a disposable housing portion 20 of a medical device system 110 may be configured to engage each other in a side-by-side arrangement, for example, as represented in FIG. 8. In the side-by-side arrangement in FIG. 8, either one or both of the durable housing portion 30 and the disposable housing portion 20 may be provided with a base having an adhesive material 101 (with or without a peelable cover layer 23 as shown in FIG. 3).

In yet further embodiments, for example, as represented in FIG. 9, one or both of a durable housing portion 30 and a disposable housing portion 20 of a medical device system 120 may be attachable and detachable from a separate base member 21′. A suitable connecting structure, such as that described above, may be employed for connecting any combination or all of the durable housing portion 30, the disposable housing portion 20, and the base member 21′. The separate base member 21′ may include a generally flat, plate-like structure made of any suitably rigid material including, but not limited to, plastic, metal, ceramic, composite material, or the like. The base member 21′ may have a surface (i.e., upper-facing surface in FIG. 9) to which the disposable housing portion 20 and the durable housing portion 30 may be attached or otherwise operatively engaged. The base member 21′ may have a second surface (i.e., lower-facing surface in FIG. 9) to which an adhesive material and a peelable cover film may be applied, as described herein, to allow the base member 21′ to be secured to a skin of a patient-user.

In some embodiments, the base member 21′ may include a needle inserter device 25, as described herein. In such embodiments, the base member 21′ may be secured to skin of a patient-user. Then, the needle inserter 25 may be activated to insert a hollow needle or cannula into the skin of the patient-user. Then, after the hollow needle or cannula is inserted, the durable housing portion 30 and the disposable housing portion 20 may be attached to the base member 21′ to connect the reservoir system 40 (e.g., FIGS. 1-6C) in fluid flow communication with the hollow needle or cannula.

In some embodiments, the durable housing portion 30 and the disposable housing portion 20 may be connected together, for example, in the manner described above, before attaching those housing portions to the base member 21′. In further embodiments, one of the durable housing portion 30 and the disposable housing portion 20 may be attached to the base member 21′ before the durable housing portion 30 and the disposable housing portion 20 are connected together. In such further embodiments, the needle inserter device may be activated to insert a hollow needle or cannula into the skin of the patient-user after the disposable housing portion 20 is attached to the base member 21′ either before or after the durable housing portion 30 and the disposable housing portion 20 are connected together.

In some embodiments, the base member 21′ may have an opening 25 that aligns with a needle inserter device (or aligns with a further opening). In such embodiments, the base member 21′ may be secured to the skin of the patient-user. Then the disposable housing portion 20 may be attached to the base member 21′ before or after the durable housing portion 30 and the disposable housing portion 20 are connected together. Once the disposable housing portion 20 is attached to the base member 21′, the needle inserter device may be activated to insert a hollow needle or cannula into skin of a patient-user either before or after the durable and disposable housing portions are connected together. Other needle/cannula insertion tools, as described throughout the disclosure, may be used (or modified for use) to insert a needle and/or cannula, such as, but not limited to, those previously described.

In some embodiments, an injection site module 103 may be provided external to a disposable housing portion 20 of a medical device system 130, but connected to the disposable housing portion 20 through a conduit 102, as shown in FIG. 10. The external injection site module 103 may include a needle or cannula injector device structure and an operator or opening (e.g., opening 25 in FIG. 9) through which such an injector device or the like may be activated. Alternatively or in addition, the external injection site module 103 may include an infusion set such as, but not limited to an infusion set as described or referenced in U.S. patent application Ser. No. 10/705,686, filed Nov. 10, 2003, titled “Subcutaneous Infusion Set” (Publication No. 2005/0101910) and/or U.S. patent application Ser. No. 11/004,594, filed Dec. 3, 2004, titled “Multi-Position Infusion Set Device And Process” (Publication No. 2006/0129090), each of which is assigned to the assignee of the present invention and incorporated herein by reference in its entirety.

The conduit 102 that connects the injection site module 103 with the disposable housing portion 20 may be any suitable tubing structure having a fluid flow passage, such as, but not limited to, a flexible tube made of plastic, silicone, polymers, or the like. An adhesive material, such as the adhesive material previously described, may be provided on the tubing structure (or between the tubing structure and the skin of the patient-user) to secure the tubing to the skin of the patient-user. An adhesive material, such as the adhesive material previously described, may be provided on the injection site module 103 (or between the injection site module 103 and the skin of the patient-user) to secure the injection site module 103 to the skin of the patient-user. By locating the injection site module 103 external to the disposable housing portion 20, the disposable housing portion 20 and the durable housing portion 30 may be clipped to clothing, belt, suspender, or other article of apparel or may be held in a pocket of an article of apparel or carried in a purse, or the like of the patient-user.

In some embodiments, the conduit 102 may be fixed at one end to the disposable housing portion 20 in fluid-flow communication with the reservoir system 40 (e.g., FIGS. 1-6C) within the disposable housing portion 20. The conduit 102 may be fixed at a second end to the external injection site module 103 for connection in fluid-flow communication with a hollow needle or cannula, as previously described.

In further embodiments, one or both of the ends of the conduit 102 may include suitable connection structures that allow the ends of the conduit 102 to be selectively connected in fluid-flow communication with and selectively disconnected from the disposable housing portion 20 and/or the injection site module 103. Such connectors may comprise a hollow needle and septum, a Luer connector, or other suitable fluid-communication connectors. In such embodiments, the disposable housing portion 20 and a durable housing portion 30 may be disconnected from the injection site module 103, for example, by disconnecting one of the ends of the conduit 102 from the injection module 103 or the disposable housing portion 20, while leaving the injection site module 103 in place. Thus, the patient-user may not need to withdraw the needle or cannula and, later, insert a needle or cannula to resume operation. In this manner, the patient-user may readily disconnect and remove the disposable housing portion 20 and durable housing portion 30, for example, to allow the patient-user to shower, bathe, swim, or conduct other activities, yet also allow the patient-user to readily re-connect the disposable housing portion 20 to the injection site module 103, for example, upon completion of such activities. Examples of connectors can be found in U.S. patent application Ser. No. 10/328,393, filed Dec. 22, 2003, and entitled “Reservoir Connector”; and U.S. Pat. No. 5,545,152 issued Aug. 13, 1996, and entitled “Quick-Connect Coupling For A Medication Infusion System,” both of which are incorporated herein by reference in their entirety. In other alternatives, different connectors such as Luer locks, or other suitable fluid-communication connectors may be used.

In some embodiments, an injection site module 103 may be directly connected with a disposable housing portion 20 of a medical device system 140, as shown in FIG. 11. In such embodiments, one or more suitable fluid flow passages are provided through the disposable housing portion 20 and into the injection site module 103 for fluid-flow communication between the reservoir system 40 (e.g., FIGS. 1-6C) in the disposable housing portion 20 and a hollow needle or cannula, as previously described. In addition, in such embodiments, the injection site module 103 and the disposable housing portion 20 may include mating connection structures to allow the injection site module 103 and the disposable housing portion 20 to be selectively connected and disconnected from each other.

Various examples of mating arrangements for directly connecting an injection site module 103 to a disposable housing portion 20 are described with reference to FIGS. 12-19. FIGS. 12-14 show an example arrangement of a medical device system 150 in which an injection site module 103 may include at least one (e.g., two in FIG. 12) protruding engagement pawl(s) 174 that are configured to be received in a corresponding number of receptacle(s) on the disposable housing portion 20. The pawl(s) 174 and the receptacle(s) may, for example, be similar to the pawls 74 and receptacles 76 described in U.S. Patent Application No. 60/839,741, titled INFUSION PUMPS AND METHODS AND DELIVERY DEVICES AND METHODS WITH SAME, filed Aug. 23, 2006, which is herein incorporated by reference in its entirety. In other embodiments, the pawl(s) 174 may be located on the disposable housing portion 20, while the corresponding receptacle(s) may be located on the injection site module 103. In yet other embodiments, each of the disposable housing portion 20 and the injection site module 103 may include one or more pawl(s) 174 and one or more receptacle(s).

The pawl(s) 174 and receptacle(s) may be configured to allow a patient-user to manually slide the pawl(s) 174 into the receptacle(s) as the disposable housing portion 20 and the injection site module 103 are brought together. By sliding the pawl(s) 174 in the corresponding receptacle(s), the injection site module 103 may be secured to the disposable housing portion 20. The pawl(s) 174 may include a shaped portion or head to provide a snap-fit with the receptacle(s) when the pawl(s) 174 are fully received within the receptacle(s). The pawl(s) 174 may be configured with sufficient flexibility to allow the patient-user to separate the disposable housing portion 20 from the injection site module 103 by applying a sufficient force to pull those two parts away from each other and unsnap the pawl(s) 174 from the receptacle(s). In the embodiments of FIGS. 12-14, the injection site module 103 may be attached to or may include a base 450 that may be secured to skin of a patient-user during operation in lieu of the extended base 21 of the disposable housing portion 20 described above. The base 450 may include an adhesive material as described herein with respect to the base 21 (or any other base described herein) of the disposable housing portion 20.

As shown in FIG. 14, the embodiments of FIGS. 12-14 may be formed in three general parts, including the disposable housing portion 20, the durable housing portion 30, and the injection site module 103 on the base 450. The durable housing portion 30 and the disposable housing portion 20 may be secured together (e.g., FIG. 12), and the combined, connected disposable and durable housing portions may be secured to the injection site module 103 and the base 450. In some embodiments, the base 450 may be secured to the skin of the patient-user, before the combined, connected disposable and durable housing portions are secured to the injection site module 103 and the base 450. In further embodiments, the combined, connected disposable and durable housing portions may be secured to the injection site module 103 and the base 450, before the base 450 is secured to the skin of the patient-user.

An example of a connection structure of a medical device system 160 is described with reference to FIGS. 15 and 16, wherein the injection site module 103 may include a shaped head 452 configured to be received within a correspondingly shaped opening or receptacle in the disposable housing portion 20. The shaped head 452 may be configured with a shape that allows the head 452 to be received in the receptacle in a case where the disposable housing portion 20 is aligned relative to the injection site module 103 in a first alignment position, as shown in FIG. 15.

The shaped head 452 may be further configured to allow the disposable housing portion 20 to be rotated relative to the injection site module 103 while the head 452 is received within the receptacle to a second alignment position, as shown in FIG. 16. The receptacle in the disposable housing portion 20 may be shaped to allow the head 452 to be freely received or removed from the receptacle when the disposable housing portion 20 is in the first alignment position (e.g., FIG. 15), yet abut the head 452 and inhibit separation of the head 452 from the receptacle in a case where the disposable housing portion 20 is in the second alignment position (e.g., FIG. 16). Accordingly, separation of the disposable housing portion 20 from the injection site module 103 may be inhibited in a case where the disposable housing 20 is in the second alignment position.

An example of a connection structure of a medical device system 170 is described with reference to FIGS. 17-19, wherein the medical device system 170 may incorporate three parts, the durable housing portion 30, the disposable housing portion 20, and a base 456. A shaped receptacle 454 on the base 456 may be configured to receive a correspondingly shaped connector member in the disposable housing portion 20. The injection site module 103 may be formed integral with the disposable housing portion 20. The shaped receptacle 454 may be configured with a shape that allows the connector member in the injection site module 103 to be engaged with the receptacle 454 in a case where the disposable housing portion 20 is aligned relative to the base 456 and receptacle 454 in a first alignment position, as shown in FIG. 17.

Returning to FIGS. 7-19, the shaped receptacle 454 may be further configured to allow the disposable housing portion 20 to be rotated relative to the base 456 and receptacle 454 in a case where the receptacle 454 is engaged within the connector member to a second alignment position, as shown in FIG. 18. Returning to FIGS. 7-19, the receptacle 454 and the connector member in the disposable housing portion 20 may be shaped to allow the connector member to freely engage the receptacle 454 in a case where the disposable housing portion 20 is in the first alignment position (e.g., FIG. 17), yet lock with the receptacle 454 and inhibit separation of the connector member from the receptacle in a case where the disposable housing portion 20 is in the second alignment position (e.g., FIG. 18). Accordingly, separation of the disposable housing portion 20 from the injection site module 103 may be inhibited in a case where the disposable housing 20 is in the second alignment position.

The receptacle 454 and connection member may include any suitable known rotary connection structure(s) for connecting two structures together upon engagement and relative rotation of the two structures in one direction, yet allow the two structures to be disengaged and separated from an engaged arrangement by relative rotation of the two structures in a second direction opposite the first direction. A motion inhibiting structure, such as a locking tab, pawl, or the like, may be provided to inhibit relative motion between the disposable housing portion 20 and the base 456, once those parts have been connected, as previously described.

As shown in FIG. 19, the embodiments of FIGS. 17-19 may be formed in three general parts, including the disposable housing portion 20, the durable housing portion 30, and the injection site module 103 on the base 456. The durable housing portion 30 and the disposable housing portion 20 may be secured together (e.g., FIG. 17), and the combined, connected disposable and durable housing portions may be secured to the base 456. In one embodiment, the base 456 may be secured to skin of a patient-user before the combined, connected disposable and durable housing portions are secured to the base 456. In further embodiments, the combined, connected disposable and durable housing portions may be secured to the base 456 before the base 456 is secured to the skin of the patient-user.

With reference to FIGS. 7-19, various aspects of the multiple embodiments described above may be employed independently or in combinations thereof. Significant advantages can be obtained from various embodiments and combinations described herein, wherein an at-site delivery system may be made of two parts, including a disposable portion and a non-disposable portion. The disposable portion may contain all materials that are in direct contact with the infusion medium, such as reservoir body, reservoir piston, septum systems, and/or injection needle. The non-disposable portion could contain substantially the materials that are not in contact with the medication including the drive system, pressure or force sensing system (and/or other sensing systems), battery, electronics, display, and/or non-disposable housing.

The pump could be designed such that the disposable portion (with an unused new, user-filled, prefilled, refurbished, remanufactured or re-filled reservoir system 40 (e.g., FIGS. 1-6C)) is inserted into the non-disposable portion. By simplifying the manner in which the disposable portion of the delivery device can be replaced and by simplifying the manner in which the delivery device can be re-activated after replacing a disposable portion, a greater number of patient-users will be able to use and benefit from such delivery devices.

In addition, while embodiments described above include an injection site located on the disposable housing portion 20 or in an external injection site module 103, other embodiments may employ an injection site located in the durable housing portion 30. The injection site may be connected through suitable fluid-flow passages to the reservoir system 40 in the disposable housing portion 20 when the durable housing portion 30 and disposable housing portion 20 are engaged.

In addition, while embodiments are described above in the context of delivery devices for delivering an infusion medium from a reservoir to a patient-user, other embodiments may be operated to withdraw fluidic media from a patient-user (or other source) and transfer the fluidic media to the reservoir. Such other embodiments may be operated by operating the drive device to selectively move the piston plunger away from the septum-end of the reservoir (to increase the fluid-retaining volume of the reservoir) to create a negative pressure sufficient to draw fluid from the patient-user (or other source) to which the hollow needle or cannula is secured.

In addition, in any of the above-described embodiments, one or both of the disposable housing portion 20 and the durable housing portion 30 (and/or a separate base portion 21′, 450, 456, or a separate injection site module 103) may include a sensor (not shown), such as a force sensor, or the like, or other suitable sensing device for sensing the proper placement or engagement of one or more of the components. In such embodiments, further electronics may control the operation of the drive device to inhibit operation of the drive device and/or the needle injector, unless the sensor senses the proper operable engagement of one or more of the components and/or the skin of the patient-user (or other suitable location).

Alternatively or in addition, one or both of the disposable housing portion 20 and the durable housing portion 30 may include a sensing device (not shown) for sensing the proper operable engagement of the disposable housing portion 20 and the durable housing portion 30 together (and/or with a separate base portion or a separate injection site module). In such an embodiment, further electronics may control the operation of the drive device to inhibit operation of the drive device and/or the needle injector, unless the sensing device senses the proper operable engagement of the disposable housing portion 20 and the durable housing portion 30 together (and/or with a separate base portion or a separate injection site module).

While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that the invention is not limited to the particular embodiments shown and described and that changes and modifications may be made without departing from the spirit and scope of the claimed invention. For example, while embodiments described above may include an adhesive material and a cover film 23 (FIGS. 2 and 3), further embodiments may include a plurality of adhesive material layers alternating with a corresponding plurality of cover film layers 23 to allow the delivery device to be secured, removed and re-secured to the skin of the patient-user one or more times.

In such embodiments, a first cover film layer located at the end of the stack of alternating layers of adhesive material and cover film may be removed to expose a first layer of adhesive material. With the first layer of adhesive material exposed, a medical device system (e.g., 100, 110, 120, 130, 140, 150, 160, 170) (or component thereof) may be adhered to skin of a patient-user, as previously described. After a suitable period of usage, the medical device system (or component having the adhesive) may be removed from the skin of the patient-user, for example, for servicing, re-filling, replacement of one or more components, or the like. After removal of the medical device system (or component) from the skin of the patient-user, a second cover film layer on the medical device system (or component) may be removed to expose a second layer of adhesive material. With the second layer of adhesive material exposed, the medical device system (or component) may be secured to the same patient-user or, in certain contexts, to a different patient-user, for further operation. The process may be repeated a number of times up to the number of adhesive material and cover film layer pairs are included in the plural alternating layers of adhesive material and cover film.

In addition, while various embodiments described above may include one or more adhesive layers, each having a peelable cover layer, other embodiments may employ a single adhesive layer having (or plural adhesive layers, each having) a pattern of plural peelable cover layer portions. Accordingly, a patient-user may peel off one portion of the cover layer for adhering a medical device system (e.g., 100, 110, 120, 130, 140, 150, 160, 170) to the patient-user as described above, while leaving the rest of the pattern of peelable cover layer portions on the adhesive. In such an embodiment, after completion of a first period of operation of the medical device system and removal of the medical device system from the patient-user, a second portion of the peelable cover layer may be removed from the adhesive layer and the medical device system may be adhered to the same patient-user or, in certain contents, to a different patient-user for a second period of operation.

In various embodiments, while various medical device system (e.g., 100, 110, 120, 130, 140, 150, 160, 170) embodiments described above may include base portions (e.g., 21, 21′, 450, 456) that are configured to be secured to skin of a patient-user (or other suitable surface of operation) and that extend along a length and/or width of the medical device system structure, other embodiments may employ base portions configured to be secured to the skin of the patient-user (or other surface) and extend less than a full length or width dimension of the medical device system structure to minimize surface area in contact with the patient-user (or other surface). Such embodiments may increase comfort of the patient-user during operation of the medical device system. Base portions having shapes and sizes different from those shown in the accompanying drawings may be employed for additional improvements with regard to the comfort of the patient-user and/or minimizing the surface area in contact with the patient-user. Furthermore, as noted above, the base portion may be composed of a flexible material that at least partially conforms to the curvature and movement of a body of the patient-user.

In any of the above-described embodiments in which an adhesive material is used to secure one or more medical device system (e.g., 100, 110, 120, 130, 140, 150, 160, 170) components to skin of a patient-user (or other suitable surface), multiple types of adhesive materials (or multiple strengths of adhesives) may be employed, such that a stronger adhesive may be provided in certain areas (e.g., around the needle injection site), while a weaker adhesive may be provided in other areas. Examples of various adhesive systems may be found in, but are not limited to, U.S. application Ser. No. 12/027,963, filed Feb. 7, 2008, entitled “Adhesive Patch Systems and Methods,” herein incorporated by reference in its entirety.

Further examples of connection and/or alignment structures are described with reference to FIGS. 20A-24B, wherein a medical device system 500 may incorporate two parts: a first housing portion 530 and a second housing portion 550. Other embodiments may include medical device systems with more than two parts.

The medical device system 500 may be similar to or employed as an embodiment of the medical device systems discussed throughout the disclosure (e.g., FIGS. 1-6C). Although the medical device system 500 may include features similar or used with the embodiments of FIGS. 1-6C, it should be understood that the medical device system 500 may also include some or all of the same features and operate in a manner similar to that shown and described in the embodiments of FIGS. 7-19 and 25A-31. In addition, some or all of the features shown in FIGS. 1-19 and 25A-31 may be combined in various ways and included in the embodiments shown in FIGS. 20A-24. Likewise, it should be understood that any of the features of the embodiments of FIGS. 20A-24 may be combined or otherwise incorporated into any of the other embodiments of FIGS. 20A-24 as well as any other embodiment herein discussed.

In various embodiments, the first housing portion 530 may be similar to the durable portion 30 (e.g., FIGS. 1-19) and may include (i.e., be integrated with) or be connected with the disposable portion 20 (e.g., FIGS. 1-19). As previously discussed with respect to FIGS. 1-6C, the durable housing portion 530 may include various components, such as, but not limited to, a drive device 80, drive motor 84, drive device linkage portion 82, and/or the like. The disposable housing portion 20, which may be integrated or connected with the first housing portion 530 may include various components, such as, but not limited to, a reservoir system 40.

Returning to FIGS. 20A-24, in various embodiments, the second housing portion 530 may be similar to any of the bases (e.g., 21, 21′, 450, 456 in FIGS. 1-19) that may be securable to skin of a patient-user during operation of the medical device system 500. The second housing portion 550 may include (i.e., be integrated with) or be connected with an injection site section 503, which may be similar to the injection module 103 (e.g., FIGS. 7-19) previously described. Other examples of injection site sections are described in, but are not limited to, U.S. patent application Ser. No. 12/553,008, filed Sep. 2, 2009, entitled “Insertion Device Systems and Methods,” herein incorporated by reference in their entirety.

The first housing portion 530 may be for securing to the second housing portion 503 and/or the injection site section 503 of the second housing portion 550. In some embodiments, the second housing portion 550 may be secured to the skin of the patient-user before the first housing portion 530 is secured to the injection site section 503 and the second housing portion 550. In further embodiments, the first housing portion 530 may be secured to the second housing portion 550 and/or the injection site section 503 of the second housing portion 550 before the second housing portion 550 is secured to the skin of the patient-user.

The second housing portion 550 may include or be connected with a receptacle structure 510 for receiving fluidic media from a reservoir (e.g., reservoir system 40 in FIGS. 1-6C). Various examples of receptacle structures as well as connection structures for connecting two or more housing portions are described in, but are not limited to, U.S. patent application Ser. No. 12/553,008, filed Sep. 2, 2009, entitled “Insertion Device Systems and Methods,” herein incorporated by reference in their entirety. In some embodiments, the receptacle structure 510 may be part of the second housing portion 550 adjacent a section of the second housing portion 550 containing the injection site section 503. In other embodiments, the receptacle structure 510 may include a housing connected or integrated with the second housing portion 550. In such embodiments, the receptacle structure 510 may be separate and apart from the injection site section 503 or adjacent the injection site section 503. In some embodiments, the injection site section 503 may be located on a different housing and connected, for example, with the receptacle structure via tubing or other fluid conduit.

The second housing portion 550 may include a fluid conduit 524. The fluid conduit 524 may be (or in fluid communication with), but is not limited to, a needle, cannula, a piercing member, and/or the like. The fluid conduit 524 may provide a fluid passage from the receptacle structure 510 to the injection site section 503. The fluid conduit 524 may be supported by a supporting structure located within the receptacle structure 510. In some embodiments, the supporting structure may be a wall integral with the receptacle structure 510. In other embodiments, the supporting structure may be any suitable structure that is generally fixed relative to the receptacle structure 510 and is able to support the fluid conduit 524 in a generally fixed relation to the receptacle structure 510.

The fluid conduit 524 may be arranged in any suitable manner to convey fluid, for example, from a reservoir to/from the patient-user. In FIGS. 23 and 24, the fluid conduit 524 is arranged to bend around a portion of the injection site section 503. As such, in various embodiments, the fluid conduit 524 may be provided on the second housing portion 550 in any suitable manner, including as a straight fluid conduit, a curved fluid conduit, or the like.

Returning to FIGS. 20A-24, the fluid conduit 524 may be made of any suitably rigid material, including, but not limited to metal, plastic, ceramic, composite materials, glass, or the like, and may have a hollow channel extending in a lengthwise dimension of the fluid conduit 524. The hollow channel in the fluid conduit 524 may be open at a location 524 a along the lengthwise dimension of the fluid conduit 524, such as, but not limited to, a first end of the fluid conduit 524. The hollow channel in the fluid conduit 524 may be open at another location 524 b along the lengthwise dimension of the fluid conduit 524, such as, but not limited to, a second end of the fluid conduit 524 opposite the first end of the fluid conduit 524. In some embodiments, the opening 524 b of the fluid conduit 524 may be connected in fluid flow communication the injection site section 503.

In some embodiments, one or more of the openings in the fluid conduit 524 may be provided with a septum 526 that may be pierceable, for example, by a sharp end (e.g., 524 b) of the fluid conduit 524. In such embodiments, the sharp end may be directed toward a surface of the septum 526 such that the septum 526 may be urged by the first housing portion 530 having a reservoir against the sharp end as the first housing portion 530 is connected to the second housing portion 550. The septum 526 may be made of any suitable material that may be pierceable by a needle (or the like), such as, but not limited to, a natural or synthetic rubber material, silicon, or the like. In some embodiments, the septum 526 may be made of a self-sealing material capable of sealing itself after a fluid conduit (and/or the like) has pierced the septum 526 and was subsequently withdrawn from the septum 526.

In some embodiments, a septum may be provided with the reservoir. The septum may be similar to the septum 526. The septum may be pierceable by a sharp end (e.g., 524 b) of the fluid conduit 524. In such embodiments, the sharp end may be directed toward a surface to allow the sharp end to pierce the septum as the first housing portion 530 is connected to the second housing portion 550.

The injection site section 503 may include a channel 540 extending through the second housing portion 550. The channel 540 may have an open end 540 a on a bottom surface of the second housing portion 550 (i.e., a surface for contacting skin of the user-patient). The channel 540 may have another open end 540 b at an upper surface of the injection site section 503 (i.e., a surface opposite the surface for contacting the skin of the user-patient). The channel 540 may have an opening 540 c for allowing the fluid conduit 524, for example via opening 524 b, to be in fluid flow communication with the channel 540.

The channel 540 may include a channel section 542 having a suitable shape and size to receive an insert structure, a needle, and/or a cannula, such as those described in U.S. patent application Ser. No. 12/553,008, filed Sep. 2, 2009, entitled “Insertion Device Systems and Methods”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006, titled “Infusion Medium Delivery system, Device And Method With Needle Inserter And Needle Inserter Device And Method”; and U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion” (each of which is assigned to the assignee of the present invention), each of which is incorporated herein by reference in its entirety.

Other examples of various insertion tools are described in U.S. Patent Application Publication No. 2002/0022855, titled “Insertion Device For An Insertion Set And Method Of Using The Same” (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. Other examples of needle/cannula insertion tools that may be used (or modified for use) to insert a needle and/or cannula, are described in, for example U.S. patent application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled “Auto Insertion Device For Silhouette Or Similar Products,” and/or U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set and Method of Using the Same,” both of which are incorporated herein by reference in their entirety.

Further examples of various insertion tools are described in, but are not limited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method,” U.S. Pat. Pub. No. US 2007/0142776, entitled “Insertion Device for an Insertion Set and Method of Using the Same,” all of which are herein incorporated by reference in their entirety.

The first housing portion 530 may support a reservoir housing 508, which may be similar to or include reservoir system 40 (e.g., FIGS. 1-6C) or the like as previously described. The reservoir housing 508 of the first housing portion 530 may include a connection portion 531, which is some embodiments may be a port portion of the reservoir housing 508. The connection portion 531 of the reservoir housing 508 may have a suitable shape and size to fit at least partially within an opening 512 of the receptacle structure 510 in the second housing portion 550 when the second housing portion 550 and the first housing portion 530 are connected together.

In the drawings of FIGS. 20A, 21A, and 22A, the second housing portion 550 and the first housing portion 530 are shown in a partially separated, disconnected relation, wherein the connection portion 531 of the reservoir housing 508 is outside of the opening 512 of the receptacle structure 510. By moving or sliding the first housing portion 530 in a first direction A relative to the second housing portion 550 to bring the first housing portion 530 and the second housing portion 550 together, the connection portion 531 of the reservoir housing 508 can be inserted into the opening 512 of the receptacle structure 510 of the second housing portion as shown in FIG. 21B. Continued relative movement of the second housing portion 550 and the first housing portion 530 together may cause the fluid conduit 524 to extend into the reservoir housing 508 as shown in FIG. 21C. in some embodiments, the continued relative movement of the second housing portion 550 and the first housing portion 530 together may cause a sharp end (e.g., 524 b) of the fluid conduit 524 to pass through one or more septa in the receptacle structure 510 and/or the reservoir housing 508.

Returning to FIGS. 20-24, thus when the second housing portion 550 and the first housing portion 530 are brought together (e.g., FIGS. 20C, 21C, 22C) such that the first housing portion 530 is moved to a position P, at least a portion of the connection portion 531 may extend inside of the receptacle structure 510 with the fluid conduit 524 extending into the interior volume of the reservoir housing 508. Accordingly, the fluid conduit 524 may form a fluid flow path between the interior volume of the reservoir housing 508 and the injection site section 503 or other structure at the opening 524 b of the fluid conduit 524. In addition or alternatively, the second housing portion 550 may be slidable in the first direction A relative to the first housing portion 530 to bring the two components together.

The receptacle structure 510 and the connection portion 531 may be provided with mating connectors that provide, for example, a snap or friction connection upon the second housing portion 550 and the first housing portion 530 being connected. In some embodiments, the mating connectors may include a protrusion (not shown) on one or the other of the receptacle structure 510 and the connection portion 531. The other of the receptacle structure 510 and the connection portion 531 may include a groove or indentation (not shown) arranged to engage each other in a snap-fitting manner upon the connection portion 531 being extended into the receptacle structure 510 a suitable distance. Various examples of sliding arrangements for operatively engaging and disengaging various components are described in, but not limited to, U.S. application Ser. No. 12/650,378, filed Dec. 30, 2009, which is herein incorporated by reference in its entirety.

Further examples of connection and/or alignment structures are described with reference to FIGS. 25A-27B, which discloses an alignment system 905 for aligning a two-part medical device system 900, which has a first housing portion 901 and a second housing portion 902. Other embodiments may directed to an alignment system for aligning medical device systems with more than two parts. For example, a medical device system may include a base 21, a durable portion 30, and a disposable portion 20 (refer to FIGS. 1-6C).

The medical device system 900 may be similar to or employed as an embodiment of the medical device system 500 (e.g., FIGS. 20A-24) and/or the other medical device systems discussed throughout the disclosure (e.g., FIGS. 1-19). Although the medical device system 900 may include features similar or used with the embodiments of FIGS. 20A-30B, it should be understood that the medical device system 900 may also include some or all of the same features and operate in a manner similar to that shown and described in the embodiments of FIGS. 1-19 and 28A-31. In addition, some or all of the features shown in FIGS. 1-24 and 28A-31 may be combined in various ways and included in the embodiments shown in FIGS. 25A-27B. Likewise, it should be understood that any of the features of the embodiments of FIGS. 25A-27B may be combined or otherwise incorporated into any of the other embodiments of FIGS. 25A-27B as well as any other embodiment herein discussed.

In various embodiments, the first housing portion 901 may be, but is not limited, to any of the housing portions described, such as the durable portion 30 (e.g., FIGS. 1-19) and the disposable portion 20 (e.g., FIGS. 1-19). In specific embodiments, the first housing portion 901 may be similar to the first housing portion 530 (e.g., FIGS. 20A-24B).

Moreover in various embodiments, the second housing portion 902 may be, but is not limited, to any of the housing portions described, such as the base 21 (or 21′, 450, 456 in FIGS. 1-19), the durable housing portion 30, and the disposable housing portion. In specific embodiments, the second housing portion 902 may be similar to the second housing portion 550 (e.g., FIGS. 20A-24B). In such embodiments, for example, the second housing portion 902 may be secured to skin of a patient-user or otherwise carried by the patient-user (e.g., secured on a belt, clothing, or the like) during operation of the medical device system 900. In various embodiments, the alignment system 905 may include a plurality of electrical contacts 910 and a shorting mechanism 920.

The first housing portion 901 may include the plurality of electrical contacts 910 including a first main electrical contact 912 and a second main electrical contact 916. The plurality of electrical contacts 910 may also include one or more other electrical contact 914. The electrical contacts 910 may be made of any suitable material such as metal, a rubber conductive pad, as well as any other electrical conductor.

In some embodiments, the other electrical contact 914 may be arranged between the first main electrical contact 912 and the second main electrical contact 916. However, the other electrical contact 914 may be arranged at any suitable location. The other electrical contact 914 may be made of the same material as the first main electrical contact 912 and/or the second main electrical contact 914. In other embodiments, the other electrical contact 914 may be made of a different material (e.g., a different conductive material, or a non-conductive material) from the first main electrical contact 912 and/or the second main electrical contact 914.

The second housing portion 902 may include the shorting mechanism 920 or the like configured to establish a short or electrical connection with at least some of the electrical contacts 910 upon connecting the first housing portion 901 and the second housing portion 902. In some embodiments, the shorting mechanism 920 may establish an electrical connection with at least some of the electrical contacts 910 in a case where the first housing portion 901 and the second housing portion 902 are connected properly or otherwise brought into a pre-defined, sufficiently aligned position and/or in a pre-defined, sufficiently close proximity. The predefined aligned position and/or proximity, for example, may correspond to a properly aligned and mutually proximate position for connection of the first housing portion 901 and the second housing portion 902 for operation. In other embodiments, the shorting mechanism 920 may be a known resistance or the like.

The shorting mechanism 920 may have a first end 922 and a second end 924 for contacting respective electrical contacts 910 on the first housing portion 901. In some embodiments, the first end 922 and the second end 924 may be arranged to contact the first main electrical contact 912 and the second main electrical contact 916 respectively when the first housing portion 901 and the second housing portion 902 are connected properly, for example, as shown in FIG. 25B. As such, the shorting mechanism 920 may contact the first main electrical contact 912 and the second main electrical contact 916, but not the other electrical contact 914. Suitable circuitry (not shown) connected to the electrical contacts 910 may be configured to detect an electrical connection or short between the first main electrical contact 912 and the second main electrical contact 916 (via the shorting mechanism 920) indicating a proper connection of the first housing portion 901 and the second housing portion 902.

Furthermore, the electrical contacts 910 and/or the shorting mechanism 920 may be arranged on their respective parts such that in a case where the first housing portion 901 and the second housing portion 902 are not properly connected, such as in FIG. 25C, an electrical connection between the first main electrical contact 912 and the second main electrical contact 916 is not be established. Accordingly, this may indicate that the first housing portion 901 and the second housing portion 902 have not been connected properly.

Returning to FIGS. 25A-25C, some embodiments in which at least one other electrical contact 914 is arranged between the first main electrical contact 912 and the second main electrical contact 916 may prevent a false detection of a proper connection of the first housing portion 901 and the second housing portion 902. For example, the circuitry may be able to distinguish between a case where a stray metal object (e.g., a metal key, paper clip, coin) or other electrical conductor contacts the first main electrical contact 912, the second main electrical contact 916, and the other contact 914 as opposed to a proper connection where only the first main electrical contact 912 and the second main electrical contact 912 are contacted (by the shorting mechanism).

In some embodiments, an electrical connection will only be established when the first end 922 contacts the first main electrical contact 912 and the second end 924 contacts the second main electrical contact 916. In other embodiments, an electrical connection may be established in a case where the first end 922 and the second end 924 contact the first main electrical contact 912 and the second main electrical contact 916 respectively or in a case where the first end 922 and the second end 924 contact the second main electrical contact 916 and the first main electrical contact 912 respectively. Such embodiments, may allow for a detection of a proper connection of the first housing portion 901 and the second housing portion 902 in more than one orientation.

In the embodiments shown in FIGS. 25A-25C, there are three electrical contacts: the first main electrical contact 912, the second main electrical contact 916, and the other electrical contact 914 arranged between the first main electrical contact 912 and the second main electrical contact 916. However, in various other embodiments, any suitable number of electrical contacts 910 may be provided on the first housing portion 901 as required. In some embodiments, the main electrical contacts (e.g., 912, 916) are arranged as the outermost electrical contacts; however, in other embodiments, the main electrical contacts may be arranged anywhere relative to the other electrical contact(s) 914.

Similarly, the other electrical contacts need not be limited to being arranged in between main electrical contacts, but may also be arranged to be the outermost electrical contact in some embodiments. As such, the electrical contacts 910 (e.g., main electrical contacts and other electrical contacts) may be arranged or otherwise provided on the first housing portion 901 in any suitable manner, for example linearly/non-linearly, equidistant/non-equidistant, similar/varying heights, arranged on similar/varying surfaces, same/different resistances, same/different materials, and/or the like. For instance, as shown in FIG. 26, seven electrical contacts 910 could be provided including two first main electrical contacts 912, a first other electrical contact 914, a second main electrical contact 916, a second other electrical contact 914, and two third main electrical contacts 918.

In the embodiments shown in FIGS. 25A-25C, the shorting mechanism 920 has two ends 922, 924 for contacting the first main electrical contact 912 and the second main electrical contact 916, respectively. However, in various other embodiments, the shorting mechanism 920 may be provided with any suitable number of ends or contact surfaces for contacting the electrical contacts 910 as required. Similarly, the ends (e.g., 922, 924) may be arranged on shorting mechanism 920 in any suitable manner.

In various embodiments, the electrical contacts 910 may be provided on the first housing portion 901 and the shorting mechanism 920 may be provided on the second housing portion 902. In other embodiments, the electrical contacts 910 may be provided on the second housing portion 902 and the shorting mechanism 920 may be provided on the first housing portion 901. In further embodiments, each of the first housing portion 901 and the second housing portion 902 may be provided with a shorting mechanism 920 and complementing electrical contacts 910.

In some embodiments, such as the embodiments shown in FIGS. 27A and 27B, a bias member 919, such as a spring, or the like, may be provided to bias the electrical contacts 910 either individually, partially (e.g., some, but not all), or collectively toward a first position (e.g., an extended position as shown in FIG. 27A). As such, the electrical contacts 910 may be moveable toward a second position (e.g., a retracted position as shown in FIG. 27B), for example, as the first housing portion 901 and the second housing portion 902 are brought together. Thus, while in the second position, an electrical connection may be established between the first main electrical contact 912 and the second main electrical contact 916 via the shorting mechanism 910 in a similar manner to that previously described. The bias member 919 may be located at least partially within a recess of the first housing portion 901. In some embodiments, the bias member 919 may be supported on the first housing portion 901, for example, between the electrical contacts 910 and the first housing portion 901.

In addition or in alternative to the above, in some embodiments, a bias member, such as a spring, or the like, may be provided to bias the shorting mechanism or portion thereof (e.g., ends 922, 924) toward a first position (e.g., an extended position). As such, shorting mechanism or portion thereof may be moveable toward a second position (e.g., a retracted position), for example, as the first housing portion 901 and the second housing portion 902 are brought together. Thus, while in the second position, an electrical connection may be established between the first main electrical contact 912 and the second main electrical contact 916 via the shorting mechanism 910 in a similar manner to that previously described.

In various embodiments, the electrical contacts 920 and/or the shorting mechanism 910 may be or otherwise comprise a bias member as described in the disclosure. For example, the electrical contacts 920 may be metal springs or the like that may be moveable from the first position to the second position as the first housing portion 901 and the second housing portion 902 are brought together. In some embodiments, the ends 922, 924 may be or otherwise comprise a bias member as described in the disclosure.

Further examples of connection and/or alignment structures are described with reference to FIGS. 28A-30, which discloses an alignment system 1105 for aligning a two-part medical device system 1100, which has a first housing portion 1101 and a second housing portion 1102. Other embodiments may directed to an alignment system for aligning medical device systems with more than two parts. For example, a medical device system may include a base 21, a durable portion 30, and a disposable portion 20 (refer to FIGS. 1-6C).

The medical device system 1100 may be similar to or employed as an embodiment of the medical device system 500 (e.g., FIGS. 20A-24) and/or the other medical device systems discussed in the disclosure (e.g., FIGS. 1-19). Although the medical device system 1100 may include features similar or used with the embodiments of FIGS. 20A-24, it should be understood that the medical device system 1100 may also include some or all of the same features and operate in a manner similar to that shown and described in the embodiments of FIGS. 1-19 and 25A-27B. In addition, some or all of the features shown in FIGS. 1-27B may be combined in various ways and included in the embodiments shown in FIGS. 28A-30. Likewise, it should be understood that any of the features of the embodiments of FIGS. 28A-30 may be combined or otherwise incorporated into any of the other embodiments of FIGS. 28A-30 as well as any other embodiment herein discussed.

In various embodiments, the first housing portion 1101 may be, but is not limited, to any of the housing portions described, such as the durable portion 30 (e.g., FIGS. 1-19) and the disposable portion 20 (e.g., FIGS. 1-19). In specific embodiments, the first housing portion 1101 may be similar to the first housing portion 530 (e.g., FIGS. 20A-24).

Moreover in various embodiments, the second housing portion 1102 may be, but is not limited, to any of the housing portions described, such as the base 21 (or 21′, 450, 456 in FIGS. 1-19), the durable housing portion 30, and the disposable housing portion. In specific embodiments, the second housing portion 1102 may be similar to the second housing portion 550 (e.g., FIGS. 20A-24). In such embodiments, the second housing portion 1102 may be secured to skin of a patient-user during operation of the medical device system 1100. In various embodiments, the alignment system 1105 may include a sensor 1110 (or the like) and a magnetic source 1120.

The first housing portion 1101 may include the sensor 1110 for sensing a magnetic field, and in specific embodiments, for sensing at least a direction (i.e., vector) of a magnetic field. Such sensors 1110 may allow for detecting a presence of a magnetic field or magnetic source independent of magnetic strength. Furthermore, sensing a direction of a magnetic field may increase the probability that the sensor 1110 is sensing the appropriate the magnetic source. The sensor 1110 may be similar to the sensors described in, but is not limited to, U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” herein incorporated by reference in its entirety. The sensor 1110 may be disposed in the first housing portion 1101 or be provided on the first housing portion 1101.

Suitable electronics may be connected to the sensor 1110 to provide a controlled power signal to selectively activate or otherwise control one or more of the sensor 1110 and/or other components as described in the disclosure. For example, the sensor 1110 may be controlled to activate upon a manual activation of a control button, switch, or other manual operator on one of the connectable components or on a remote-controller device (not shown) connected in wireless communication with the sensor 1110 through suitable control electronics. In particular embodiments, the sensor 1110 may be controlled to activate upon alignment, for example, as discussed with respect to FIGS. 25A-26. For instance, alignment of the end 922 with the first main electrical contact 912 and the end 924 with the second electrical contact 916 may establish an electrical circuit for activating (e.g., providing power, providing an enabling signal, and/or the like) the sensor 1110 or other component that activates the sensor 1110. With reference to FIGS. 28A-28B, as another example, the sensor 1110 may be controlled to activate automatically after a certain action, such as activation of a button, and/or the like or after a certain amount of time. In some embodiments, the sensor 1110 may be controlled to activate upon activation or insertion of a particular component or device, such as, but not limited to, a needle inserter to insert a needle or cannula.

Examples of various needle insertion tools are described in, but are not limited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method,” all of which are herein incorporated by reference in their entirety. Thus, in such examples, the sensor 1110 may be activated, for example, before or after, the first housing portion 1101 and the second housing portion 1102 are brought operatively engaged.

The second housing portion 1102 may include the magnetic source 1120 or the like for providing a magnetic field having a direction. The magnetic source 1120 may be arranged on or in the second housing portion 1102 at a location to allow the magnetic field and/or the direction of the magnetic field of the magnetic source 1120 to be detectable by the sensor 1110 in a case where the first housing portion and the second housing portion 1102 are connected properly or otherwise brought into a pre-defined, sufficiently aligned position and/or in a pre-defined, sufficiently close proximity. The predefined aligned position and/or proximity, for example, may correspond to a properly aligned and mutually proximate position for connection of the first housing portion 1101 and the second housing portion 1102 for operation. Detection of the magnetic field and/or the direction of the magnetic field of the magnetic source 1120 may indicate that the first housing portion 1101 and the second housing portion 1102 have been connected properly.

In some embodiments, the magnetic source 1120 may be in contact with the sensor 1110 to allow the sensor 1120 to detect the magnetic field and/or direction of the magnetic field of the magnetic source 1120. In other embodiments, the magnetic source 1120 need not be in contact with the sensor 1110 to allow the sensor 1110 to detect the magnetic field and/or direction of the magnetic field of the magnetic source 1120. For example, a portion of one or both of the first housing portion 1101 and the second housing portion 1102 may be arranged between the sensor 1110 and the magnetic source 1120.

Furthermore, the sensor 1110 and the magnetic source 1120 may be arranged such that in a case where the first housing portion 1101 and the second housing portion 1102 are not been properly connected, the sensor 1110 will not be able to detect the magnetic field and/or the direction of the magnetic field, for example, because the sensor 1110 and the magnetic source 1120 are too far apart. Accordingly, this may indicate that the first housing portion 1101 and the second housing portion 1102 have not been connected properly.

In some embodiments, the magnetic source 1120 may provide more than one magnetic fields and/or directions of magnetic fields. As shown for example in FIGS. 29A and 29B, a first field 1122, a second field 1124, and a third field 1126 are provided in which the first field 1122 and the third field 1126 have a direction different from a direction of the second field 1124. In such an example, the sensor 1110 may be configured to detect only the second field 1124 and/or the direction (e.g., North) of the second field 1124 in a manner previously described. Thus, detection of the second field 1124 and/or the direction of the second field 1124 may indicate that the first housing portion 1101 and the second housing portion 1102 have been connected properly.

In further embodiments, the sensor 1110 may be configured to detect other fields (e.g., first field 1122 and second field 1126) and/or directions of the other fields such that detection of the other fields and/or directions of the other fields may indicate an improper connection of the first housing portion 1101 and the second housing portion 1102. The electronics may employ an algorithm for processing information relating to the various fields and/or other related information (e.g., magnetic field strength, gauss level, and/or the like). In particular embodiments, the detected other fields and/or the detected directions of the other fields may indicate that the device is in a particular state. For instance, a detected field having a gauss level within a particular threshold may indicate that the first housing portion 1101 and the second housing portion 1102 have been correctly aligned. Or for instance, a detected field having a gauss level below a particular threshold by a certain magnitude may indicate the first housing portion 1101 and the second housing portion 1102 are misaligned by a distance corresponding to the certain magnitude.

In some embodiments, such as the embodiments shown in FIGS. 29A-30 the first housing portion 1101 may have a sensor 1111 for sensing a gauss level or the like of a magnetic source. The sensor 1111 may be similar to the sensor 1110 previously described or any of the sensors described in, but is not limited to, U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” herein incorporated by reference in its entirety. The sensor 1111 may be disposed in the first housing portion 1101 or be provided on the first housing portion 1101.

Suitable electronics may be connected to the sensor 1111 to provide a controlled power signal to selectively activate or otherwise control one or more of the sensor 1111 and/or other components as described throughout the disclosure. For example, the sensor 1111 may be controlled to activate upon a manual activation of a control button, switch, or other manual operator on one of the connectable components or on a remote-controller device (not shown) connected in wireless communication with the sensor 1111 through suitable control electronics. In particular embodiments, the sensor 1111 may be controlled to activate upon alignment, for example, as discussed with respect to FIGS. 25A-26. For instance, alignment of the end 922 with the first main electrical contact 912 and the end 924 with the second electrical contact 916 may establish an electrical circuit for activating (e.g., providing power, providing an enabling signal, and/or the like) the sensor 1111 or other component that activates the sensor 1111. With reference to FIGS. 29A-29B, as another example, the sensor 1111 may be controlled to activate automatically after a certain action, such as activation of a button, and/or the like or after a certain amount of time. In some embodiments, the sensor 1111 may be controlled to activate upon activation or insertion of a particular component or device, such as, but not limited to, a needle inserter to insert a needle or cannula.

Examples of various needle insertion tools are described in, but are not limited to, U.S. patent application Ser. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method”; U.S. patent application Ser. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And Method With Needle Inserter And Needle Inserter Device And Method,” all of which are herein incorporated by reference in their entirety. Thus, in such examples, the sensor 1111 may be activated, for example, before or after, the first housing portion 1101 and the second housing portion 1102 are brought operatively engaged.

The second housing portion 1102 may include a magnetic source 1121 or the like for providing a certain gauss level. The magnetic source 1121 may be similar to the magnetic source 1120 previously described or any of the magnetic sources described in, but is not limited to, U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” herein incorporated by reference in its entirety.

The magnetic source 1121 may be arranged on or in the second housing portion 1102 at a location to allow the gauss level of the magnetic source 1121 to be detectable and/or measurable by the sensor 1110 in a case where the first housing portion and the second housing portion 1102 are connected properly. Detection of gauss level of the magnetic source 1121 may indicate that the first housing portion 1101 and the second housing portion 1102 have been connected properly. In further embodiments, the sensor 1111 and/or associated electronics may be configured to detect a gauss level that is within a specified range. In such embodiments, a gauss level that is below or exceeds the specified range may indicate an improper connection.

In some embodiments, the magnetic source 1121 may be in contact with the sensor 1111 to allow the sensor 1111 to detect the gauss level of the magnetic source 1121. In other embodiments, the magnetic source 1121 need not be in contact with the sensor 1111 to allow the sensor 1111 to detect the gauss level of the magnetic source 1121. For example, a portion of one or both of the first housing portion 1101 and the second housing portion 1102 may be arranged between the sensor 1111 and the magnetic source 1121.

Furthermore, the sensor 1111 and the magnetic source 1121 may be arranged such that in a case where the first housing portion 1101 and the second housing portion 1102 are not been properly connected, the sensor 1111 will not be able to detect the gauss level (or the gauss level is not within a detectable range) of the magnetic source 1121, for example, because the sensor 1111 and the magnetic source 1121 are too far apart. Accordingly, this may indicate that the first housing portion 1101 and the second housing portion 1102 have not been connected properly.

In further embodiments, electronics (not shown), such as a magnetic threshold switch (e.g., hall switch, reed switch, and/or the like), or the like, associated with the sensor 1111 may be configured to provide a signal or the like upon the sensor 1111 (or other sensor) sensing a signal outside a second range, which in some embodiments may be the same the specified range. In other embodiments, the second range may be different from the specified range. For example, the electronics may provide a signal to the control electronics of the medical device system 1100 to disable the medical device system 1100 or certain portions thereof if a gauss level beyond the second range is detected. Such embodiments may detect the various electronics of the medical device system 1100 in a case where the medical device system 1100 is in operation and is exposed to a strong external magnetic influence, such as an MRI (magnetic resonance imaging) machine, or the like.

In some embodiments, the magnetic source 1121 may provide more than one gauss level. In such embodiments, the sensor 1111 may be configured to detect only a particular gauss level (or range of levels) corresponding to a proper connection of the first housing portion 1101 and the second housing portion 1102, for instance as discussed in the disclosure. Thus, detection of the particular gauss level (or range of levels) may indicate that the first housing portion 1101 and the second housing portion 1102 have been connected properly. In further embodiments, the sensor 1111 may be configured to detect other gauss levels (or range of levels) such that detection of the other gauss levels may indicate an improper connection of the first housing portion 1101 and the second housing portion 1102. The electronics may employ an algorithm for processing information relating to the various gauss levels and/or other related information (e.g., magnetic field strength, direction of a field, and/or the like).

With reference to FIGS. 28A-30, in various embodiments, the sensor 1110 and the sensor 1111 may be the same sensor and thus may be configured to sense both a direction of magnetic field and a gauss level from a magnetic source. In some embodiments, the sensor 1110 and the sensor 1111 may both provided for sensing a magnetic source (e.g., 1120, 1121) as previously described. The sensor 1110 and the sensor 1111 may be arranged to sense the same magnetic source or respective magnetic sources. In further embodiments, the electronics may employ an algorithm for processing information relating to the various gauss levels, field directions, and/or other related information.

In various embodiments, the sensor 1110, 1111 may be provided on the first housing portion 1101 and the magnetic source 1120, 1121 may be provided on the second housing portion 1102. In other embodiments, the sensor 1110, 1111 may be provided on the second housing portion 1102 and the magnetic source 1120, 1121 may be provided on the first housing portion 1101. In further embodiments, each of the first housing portion 1101 and the second housing portion 1102 may be provided with a sensor (e.g., 1110, 1111) and complementing magnetic source (e.g., 1120, 1121).

With reference to FIGS. 25A-30, the sensors and/or the electrical contacts may be in electrical communication with electronics (not shown). The electronics may be incorporated within control electronics for controlling a drive device 44 (e.g., FIG. 4) such as, but not limited to, control electronics 52 (e.g., FIG. 4) for controlling the drive device 44. Alternatively, the electronics may be separate from and in addition to the control electronics 52, but connected in electrical communication with the control electronics 52 and/or the drive device 44 to provide a drive control signal to the drive device 44. More specifically, the electronics may be configured to inhibit operation of the drive device 44, unless a signal or a change in state is received by the control electronics 52.

The electronics and/or the control electronics 52 (e.g., FIG. 4) may be configured to control the drive device 44 (e.g., FIG. 4) in various manners in accordance with various embodiments of the invention. Examples are discussed in, but are not limited to, U.S. patent application Ser. No. 11/759,725, entitled “Infusion Medium Delivery Device and Method with Drive Device for Driving Plunger in Reservoir”; and U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” both of which are herein incorporated by reference in their entirety.

For example, the drive device 44 may be controlled to stop pumping (delivery) operation upon a detection of an interruption of a fluid-flow path or a disconnection of a critical component in the medical device system (e.g., 900, 1100). These may include, but are not limited to, a disconnection of a housing portion from another housing portion or from a base portion, a disconnection of a conduit from another conduit or from a reservoir, a disconnection of a reservoir from a housing portion or a base, and/or the like.

In yet further embodiments, additional sensors may be provided within the medical device system and connected for electrical communication with the electronics 414. Such additional sensors may comprise magnetically and/or electronically actuating switches, magnetic and/or electric field magnitude and direction sensors, inductive sensors, other proximity sensors, contact sensors, and/or the like for providing a detectable signal or change in a state upon proper connection of other components in the medical device system. Such proper connection of other components may comprise, for example, one or more of a proper connection of a reservoir into a housing portion or base, a proper connection of a conduit to a reservoir, a proper connection of two conduits together, a proper setting of a needle or cannula in an inserted state, a proper connection of a conduit to a cannula or needle, or a proper connection of other components of or to the medical device system.

In alternative or in addition, the electronics and/or the control electronics 52 (e.g., FIG. 4) may be configured to detect a first-time connection of a first housing portion (e.g., 901) and a second housing portion (e.g., 902) or a first-time connection of other components, as compared to a re-connection after previous or partial usage. In this manner, the drive device 44 may be controlled to provide a priming operation or other suitable first-time operation(s) upon detection of a first-time connection of the first part 401 and the second part 402.

In various embodiments, the sensors, electrical contacts, and/or associated circuitry may allow for, but is not limited to, tracking a number of times a component has been connected to and/or disconnected from other components, verifying proper connection and/or alignment of components in a medication delivery system prior to each delivery step, checking, sensing, and/or measuring parameters, such as ambient parameters (e.g., ambient magnetic fields), operating parameters, and/or the like, alerting users to conditions, such as conditions outside operating parameters of the delivery system, and/or the like.

Various embodiments may allow for verification between two (or more) distinct and separate components, verification of correct positioning between the two (or more) distinct and separate components, verification that the two (or more) distinct and separate components have been connected in the correct order, a safety mechanism to provide notification of separation (intentional or accidental) of any individual component in a multi-component system, and/or the like.

In alternative or in addition, the electronics and/or the control electronics 52 (e.g., FIG. 4) may be configured to provide a user-perceptible indication of a proper alignment and/or connection of the first housing portion and the second housing portion or of other components. For example, upon detection of a proper alignment and/or connection of the first housing portion and the second housing portion 402, electronic circuitry 410 and/or the control electronics 52 may provide a suitable control signal to activate an indicator device 420, as shown in FIG. 36.

The indicator device 420 may operated by a processor 422. The processor 422 may be configured to execute various programs and/or to process various information, such as data received from one or more sensors, responsive devices, and/or other interactive elements. The processor 422, for example, may be configured to compare detected signals with thresholds and/or pre-stored values in memory 424.

With reference to FIGS. 25A-30, the indicator device 420 may include, but is not limited to, an audible indicator, an optical indicator, a tactile indicator, combinations of one or more those indicators, and/or the like. For example, upon a proper alignment or connection of components as described above, an audible beeping sound or other suitable sound may be generated by a sound generating device in or associated with one or both of the first housing portion and the second housing portion. For example, upon a proper alignment or connection of components as described above, a flashing light or other suitable visual indicator may be generated by an LED or other light source or a display device on or associated with one or both of the first housing portion and the second housing portion. For example, upon a proper alignment or connection of components as described above, a vibration and/or the like may be generated by a vibration device and/or the like in or associated with one or both of the first housing portion and the second housing portion. Examples of indicator devices are discussed in, but are not limited to, U.S. patent application Ser. No. 11/759,725, entitled “Infusion Medium Delivery Device and Method with Drive Device for Driving Plunger in Reservoir”; and U.S. patent application Ser. No. 12/649,619, filed Dec. 30, 2009, entitled “Alignment Systems and Methods,” both of which are herein incorporated by reference in their entirety.

In various embodiments, the alignment structures 905, 1105 may be employed together (and/or with other alignment structures). In some embodiments, each alignment structure 905, 1105 may provide a signal or be a variable in an algorithm or the like for determining whether the first housing portion 901, 1101 and the second housing portion 902, 1102 are operatively engaged properly based on each of the alignment structures 905, 1105. In other embodiments, each alignment structure 905, 1105 may serve as a redundancy to the other alignment structure 905, 1105.

For instance, as previously discussed, the electronic circuitry 410 may provide a signal or a change in state upon both (i) the first end 922 and the second end 924 interacting with the first main contact 912 and the second main contact 916, for example, in a case where the first housing portion 901 and the second housing portion 902 are in proper alignment and sufficiently close in proximity to connect for operation and (ii) the sensor 1110, 1111 detects/measures the gauss level of the magnetic source 1120, 1121 to be detectable and/or measurable by the sensor 1110, 1111. In other words, the drive device 44 may be inoperable unless the first housing portion 901, 1101 and the second housing portion 902, 1102 are operatively engaged properly (i.e., aligned and/or connected properly).

In particular embodiments, different signals or changes in states may be provided depending how the first housing portion 901, 1101 and the second housing portion 902, 1102 are operatively engaged (or not engaged).

In some embodiments, the electronic circuitry 410 may provide different signal or changes in states based on the interactions of each of the alignment structures 905, 1105, for example, as shown in FIG. 31. With reference to FIGS. 25A-31, the circuitry 410 may provide a first signal when the first housing portion 901, 1101 and the second housing portion 902, 1102 are brought together, the shorting mechanism 920 interacts with the set of main electrical contacts 912, 916 of the plurality of electrical contacts 910, and the sensor 1110, 1111 detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source 1120, 1121. As such, the first signal may indicate that the first housing portion 901, 1101 and the second housing portion 902, 1102 have been operatively engaged properly.

The electronic circuitry 410 may provide a second signal when the first housing portion 901, 1101 and the second housing portion 902, 1102 are brought together, the shorting mechanism 920 interacts with the set of main electrical contacts 912, 916 of the plurality of electrical contacts 910, and the sensor 1110, 1111 detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source 1120, 1121. As such, the second signal may indicate that the first housing portion 901, 1101 and the second housing portion 902, 1102 have not been operatively engaged properly, and/or more specifically that the shorting mechanism 920 is interacting with the main electrical contacts 912, 916, but the sensor 1110, 1111 is not detecting the certain magnetic field or the certain magnetic strength of the magnetic source 1120, 1121.

The electronic circuitry 410 may provide a third signal when the first housing portion 901, 1101 and the second housing portion 902, 1102 are brought together, the shorting mechanism 920 interacts with the at least one other electrical contact 914 of the plurality of electrical contacts 910, and the sensor 1110, 1111 detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source 1120, 1121. As such, the third signal may indicate that the first housing portion 901, 1101 and the second housing portion 902, 1102 have not been operatively engaged properly, and/or more specifically that the sensor 1110, 1111 is detecting at least one of the certain magnetic field and magnetic strength of the magnetic source 1120, 1121, but the shorting mechanism 920 is interacting with one of the other electrical contacts 914.

The electronic circuitry 410 may provide a fourth signal when the first housing portion 901, 1101 and the second housing portion 902, 1102 are brought together, the shorting mechanism 920 interacts with the at least one other electrical contact 914 of the plurality of electrical contacts 910, and the sensor 1110, 1111 detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source 1120, 1121. As such, the fourth signal may indicate that the first housing portion 901, 1101 and the second housing portion 902, 1102 have not been operatively engaged properly, and/or more specifically that neither the shorting mechanism 920 is interacting with main electrical contacts 912, 916 nor is the sensor 1110, 1111 detecting the certain magnetic field or the certain magnetic strength of the magnetic source 1120, 1121.

The above exemplary embodiments two alignment structures, and two different statutes (detection/interaction or no detection/interaction) to provide four signals. However, other embodiments may employ any number of alignment structures and/or any number of statuses (e.g., quantifiable values) to provide any desired amount of signals.

In various embodiments, each of the alignment structures 905, 1105 may be used to provide alignment information. For instance, the alignment structures 905, 1105 may be used to provide alignment information in at least two dimensions. For example, the electrical contact alignment structure 905 may be used to provide alignment information in a first direction (e.g., along the X-axis or width dimension) and the magnetic sensor alignment structure 1105 may be used to provide alignment information in a second direction (e.g., along the Y-axis or length dimension) transverse the first direction. Thus, for example, the first signal may indicate the first housing portion 901, 1101 and the second housing portion 902, 1102 are properly aligned in the X- and Y-axis; the second signal may indicate proper alignment along the X-axis, but not the Y-axis; the third signal may indicate proper alignment along the Y-axis, but not the X-axis; the fourth signal may indicate that there is no proper alignment along the X- or Y-axis.

As discussed, these signals may be transmitted, for example, to the indicator device 425, for example, to provide an indication to the user. With such information, the user can attempt to align or re-connect the first housing portion 901, 1101 and the second housing portion 902, 1102. As another example, these signals may be transmitted to control electronics or the like to control the medical device based on the signals. For instance, as previously discussed, the signals (e.g., the fourth signal) may cause the control electronics or the like to deactivate the medical device system or a portion thereof (e.g., the pumping mechanism).

In further embodiments, the alignment structures 905, 1105 may provide alignment in a third direction (e.g., along the Z-axis or height dimension) transverse the first and second directions. For instance, if the sensor 1110, 1111 detects the certain magnetic field, but the magnetic strength is not sufficiently strong, a signal may be provided indicating that the components are aligned, but not fully connected in the Z-axis.

The embodiments disclosed herein are to be considered in all respects as illustrative, and not restrictive of the invention. The present invention is in no way limited to the embodiments described above. Various modifications and changes may be made to the embodiments without departing from the spirit and scope of the invention. The scope of the invention is indicated by the attached claims, rather than the embodiments. Various modifications and changes that come within the meaning and range of equivalency of the claims are intended to be within the scope of the invention. 

What is claimed is:
 1. A medical device for treating a user, the medical device comprising: a first housing portion adapted to be carried by a user; a second housing portion configured to be selectively operatively engaged with and disengaged from the first housing portion; a plurality of electrical contacts provided on at least one of the first housing portion and the second housing portion, the plurality of electrical contacts including a set of main electrical contacts and at least one other electrical contact; a shorting mechanism provided on the other of the first housing portion and the second housing portion, the shorting mechanism for interacting with the set of main electrical contacts; a magnetic source having at least one of a certain magnetic field and a certain magnetic strength provided on at least one of the first housing portion and the second housing portion; and electronic circuitry configured to provide a first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and a sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; the electronic circuitry further configured to provide a second signal when the first housing portion and the second housing portion are brought together and at least one of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.
 2. The medical device of claim 1, wherein the first signal indicates that the first housing portion and the second housing portion have been connected.
 3. The medical device of claim 2, wherein the second signal indicates that the first housing portion and the second housing portion have not been connected.
 4. The medical device of claim 1, wherein the first signal is a different signal from the second signal.
 5. The medical device of claim 1, the electronic circuitry further configured to provide the second signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.
 6. The medical device of claim 5, the electronic circuitry further configured to provide a third signal when the first housing portion and the second housing portion are brought together, the shorting mechanism fails to interact with the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.
 7. The medical device of claim 6, wherein the third signal indicates that the first housing portion and the second housing portion have not been connected.
 8. The medical device of claim 6, wherein the second signal is different from the third signal.
 9. The medical device of claim 6, the electronic circuitry further configured to provide a fourth signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.
 10. The medical device of claim 1, the electronic circuitry comprising first electronic circuitry configured to provide a first signal in a case where the first housing portion and the second housing portion are brought together and the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, the first electronic circuitry further configured to provide a second signal in a case where the first housing portion and the second housing portion are brought together and the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts.
 11. The medical device of claim 10, the electronic circuitry further comprising second electronic circuitry configured to provide a first signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source, the second electronic circuitry further configured to provide a second signal in a case where the first housing portion and the second housing portion are brought together and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.
 12. The medical device of claim 1, wherein the set of main electrical contacts interact with the shorting mechanism when the shorting mechanism contacts the set of main electrical contacts; the electronic circuitry configured to provide the first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism contacts the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; the electronic circuitry further configured to provide the second signal when the first housing portion and the second housing portion are brought together, the shorting mechanism contacts the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.
 13. The medical device of claim 1, the shorting mechanism having a plurality of ends, each of the ends for interacting with a respective main electrical contact of the set of main electrical contacts; the circuitry configured to provide the first signal when the first housing portion and the second housing portion are brought together, each of the ends of the shorting mechanism interacts with the respective main electrical contact of the set of main electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; the circuitry further configured to provide the second signal when the first housing portion and the second housing portion are brought together, at least one of the ends of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.
 14. The medical device of claim 13, the set of main electrical contacts comprising a first main electrical contact and a second main electrical contact; the plurality of ends of the shorting mechanism including a first end and a second end for interacting with the first main electrical contact and the second main electrical contact; the circuitry configured to provide the first signal when the first housing portion and the second housing portion are brought together, the first end and the second end of the shorting mechanism interacts with the first main electrical contact and the second main electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; the circuitry further configured to provide the second signal when the first housing portion and the second housing portion are brought together, at least one of the first end and the second end of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts, and the sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source.
 15. The medical device of claim 1, the set of main electrical contacts comprising a first main electrical contact and a second main electrical contact, the shorting mechanism having a first end and a second end for electrically connecting with and the first main electrical contact and the second main electrical contact respectively and electrically shorting the first main electrical contact with the second main electrical contact when the shorting mechanism interacts with the set of main electrical contacts.
 16. The medical device of claim 1, wherein at least one of the at least one other electrical contact is arranged between the set of main electrical contacts.
 17. The medical device of claim 1, wherein all of the at least one other electrical contact is arranged in between the set of main electrical contacts.
 18. The medical device of claim 1, wherein the shorting mechanism is configured to establish an electrical connection between the set of main electrical contacts when the shorting mechanism interacts with the set of main electrical contacts.
 19. The medical device of claim 18, wherein the shorting mechanism comprises an electrical conductor.
 20. The medical device of claim 1, wherein the set of main electrical contacts is configured to be biased toward a first position and urgeable to a second position from the first position; and wherein the set of main electrical contacts is configured to be moved to the second position when the first housing portion is engaged with the second housing portion.
 21. The medical device of claim 20, the device further comprising: a bias member for biasing the set of main electrical contacts toward the first position.
 22. The medical device of claim 21, wherein the bias member comprises a spring.
 23. The medical device of claim 21, the bias member comprising individual bias members, each of the individual bias members for biasing one of the set of main electrical contacts toward the first position.
 24. The medical device of claim 1, wherein the plurality of the electrical contacts are configured to be biased toward a first position and urgeable to a second position from the first position; and wherein the plurality of electrical contacts are moved to the second position when the first housing portion is engaged with the second housing portion.
 25. The medical device of claim 1, wherein the shorting mechanism is configured to be biased toward a first position and urgeable to a second position from the first position; and wherein the shorting mechanism is configured to be moved to the second position when the first housing portion is engaged with the second housing portion.
 26. The medical device of claim 1, wherein each of the main electrical contacts of the set of main electrical contacts comprise a conductive pad.
 27. The medical device of claim 1, wherein the plurality of electrical contacts are provided in the second housing portion, the second housing portion having a power source for providing power to electronics in the second housing portion; and wherein at least some of the plurality of electrical contacts are configured to be engageable with an electrical source for charging the power source in the second housing portion.
 28. The medical device of claim 1, wherein the plurality of electrical contacts are provided in the second housing portion, the second housing portion having programmable circuitry; and wherein at least some of the plurality of electrical contacts are configured to be engageable with an input device for programming the programmable circuitry in the second housing portion.
 29. The medical device of claim 1, wherein the plurality of electrical contacts are provided in the second housing portion, the electronic circuitry configured to determine a type of the second housing portion based on one of the plurality of electrical contacts and the shorting mechanism of the first housing portion.
 30. The medical device of claim 1, wherein the shorting mechanism comprises a known resistance.
 31. The medical device of claim 1, the sensor configured to provide a signal for activating control circuitry in a case where the sensor detects a gauss level exceeding a first pre-defined threshold value.
 32. The medical device of claim 31, wherein the sensor comprises a magnetic threshold switch.
 33. The medical device of claim 31, the sensor configured to provide a signal for deactivating at least one of the control circuitry and the sensor in a case where the sensor detects a gauss level exceeding a second pre-defined threshold value, wherein the second pre-defined threshold value is greater than the first pre-defined threshold value.
 34. The medical device of claim 1, the magnetic source having a certain magnetic field direction; the sensor for detecting the certain magnetic field direction; the electronic circuitry configured to provide the first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and the sensor detects the certain magnetic field direction.
 35. The medical device of claim 34, the electronic circuitry further configured to provide the second signal when the first housing portion and the second housing portion are brought together and at least one of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts and the sensor detects at least one of a magnetic field different from the certain magnetic field and the sensor detects a magnetic field direction different from the certain magnetic field direction.
 36. The medical device of claim 1, wherein the certain magnetic field includes a direction, the sensor configured for detecting the direction of the certain magnetic field.
 37. A method of manufacturing a medical device for treating a user, the method comprising: adapting a first housing portion to be carried by a user; configuring a second housing portion to be selectively operatively engaged with and disengaged from the first housing portion; providing a plurality of electrical contacts on at least one of the first housing portion and the second housing portion, the plurality of electrical contacts including a set of main electrical contacts and at least one other electrical contact; providing a shorting mechanism on the other of the first housing portion and the second housing portion, the shorting mechanism for interacting with the set of main electrical contacts; providing a magnetic source having at least one of a certain magnetic field and a certain magnetic strength on at least one of the first housing portion and the second housing portion; configuring electronic circuitry to provide a first signal when the first housing portion and the second housing portion are brought together, the shorting mechanism interacts with the set of main electrical contacts of the plurality of electrical contacts, and a sensor detects at least one of the certain magnetic field and the certain magnetic strength of the magnetic source; and configuring the electronic circuitry to provide a second signal when the first housing portion and the second housing portion are brought together and at least one of the shorting mechanism interacts with the at least one other electrical contact of the plurality of electrical contacts and the sensor detects at least one of a magnetic field different from the certain magnetic field and a magnetic strength different from the certain magnetic strength of the magnetic source.
 38. The medical device of claim 15, wherein one of the first and second ends of the shorting mechanism electrically connects with the at least one other electrical contact when the shorting mechanism interacts with the at least one other electrical contact.
 39. The medical device of claim 38, wherein the at least one other electrical contact is arranged in between the set of main electrical contacts. 